Study of Novel Treatment Combinations in Patients With Lung Cancer

NCT05633667 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: GS-US-624-6376MOH_2022-12-13_012231
• Study Type: interventional
• Target: 270
• Locations: 8 countries
• Sites: 100

Brief Summary

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.

Conditions

Lung Cancer; Advanced or Metastatic Non-Small-Cell Lung Cancer; Resectable Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.

  Up to 5 years

• Substudy 03: Complete Pathological Response (pCR) Rate

  pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.

  Up to 5 years

Secondary Outcomes (7)

• Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1

  Up to 5 years

• Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1

  Up to 5 years

• All Substudies: Overall survival (OS)

  Up to 5 years

• Substudy 03: Event-Free Survival (EFS)

  Up to 5 years

• Substudy 03: Major Pathological Response (MPR) Rate

  Up to 5 years

Study Arms (10)

Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)

EXPERIMENTAL

Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.

Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Sacituzumab govitecan-hziy (SG)

Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)

EXPERIMENTAL

Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Etrumadenant (ETRUMA)

Substudy 01: ZIM + ETRUMA

EXPERIMENTAL

Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Drug: Zimberelimab (ZIM); Drug: Etrumadenant (ETRUMA)

Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)

EXPERIMENTAL

Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.

Drug: Zimberelimab (ZIM); Drug: Sacituzumab govitecan-hziy (SG)

Substudy 01: ZIM + Platinum Based Chemotherapy

ACTIVE COMPARATOR

Expansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology).

Drug: Zimberelimab (ZIM); Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel

Substudy 02: SG + ZIM + ETRUMA

EXPERIMENTAL

Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Drug: Zimberelimab (ZIM); Drug: Sacituzumab govitecan-hziy (SG); Drug: Etrumadenant (ETRUMA)

Substudy 02: Either Docetaxel or SG (Monotherapy Only)

ACTIVE COMPARATOR

Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Drug: Sacituzumab govitecan-hziy (SG); Drug: Docetaxel

Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy

EXPERIMENTAL

Participants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).

Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel

Substudy 03 - ZIM + Platinum-based Chemotherapy

EXPERIMENTAL

Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).

Drug: Zimberelimab (ZIM); Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel

Substudy 03: Nivolumab + Platinum-based Chemotherapy

ACTIVE COMPARATOR

Participants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).

Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nivolumab

Interventions

Zimberelimab (ZIM) DRUG

Administered intravenously

Also known as: AB122, GS-0122

Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA); Substudy 01: ZIM + ETRUMA; Substudy 01: ZIM + Platinum Based Chemotherapy; Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG); Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM); Substudy 02: SG + ZIM + ETRUMA; Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy; Substudy 03 - ZIM + Platinum-based Chemotherapy

Domvanalimab (DOM) DRUG

Administered intravenously

Also known as: AB154, GS-0154

Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA); Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM); Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy

Sacituzumab govitecan-hziy (SG) DRUG

Administered intravenously

Also known as: GS-0132, IMMU-132

Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG); Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM); Substudy 02: Either Docetaxel or SG (Monotherapy Only); Substudy 02: SG + ZIM + ETRUMA

Etrumadenant (ETRUMA) DRUG

Administered orally

Also known as: AB928, GS-0928

Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA); Substudy 01: ZIM + ETRUMA; Substudy 02: SG + ZIM + ETRUMA

Carboplatin DRUG

Administered intravenously

Substudy 01: ZIM + Platinum Based Chemotherapy; Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy; Substudy 03 - ZIM + Platinum-based Chemotherapy; Substudy 03: Nivolumab + Platinum-based Chemotherapy

Cisplatin DRUG

Administered intravenously

Substudy 01: ZIM + Platinum Based Chemotherapy

Pemetrexed DRUG

Administered intravenously

Substudy 01: ZIM + Platinum Based Chemotherapy; Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy; Substudy 03 - ZIM + Platinum-based Chemotherapy; Substudy 03: Nivolumab + Platinum-based Chemotherapy

Paclitaxel DRUG

Administered intravenously

Substudy 01: ZIM + Platinum Based Chemotherapy; Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy; Substudy 03 - ZIM + Platinum-based Chemotherapy; Substudy 03: Nivolumab + Platinum-based Chemotherapy

Nab-paclitaxel DRUG

Administered intravenously

Substudy 01: ZIM + Platinum Based Chemotherapy

Docetaxel DRUG

Administered intravenously

Substudy 02: Either Docetaxel or SG (Monotherapy Only)

Nivolumab DRUG

Administered intravenously

Substudy 03: Nivolumab + Platinum-based Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Substudies:
• Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
• No known actionable genomic alterations for which targeted therapies are available.
• Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
• Measurable disease per response evaluation criteria in solid tumors.
• Adequate hematologic and end-organ function.
• Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
• Substudy 01: All Experimental arms
• Stage IV NSCLC.
• For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
• PD-L1 status by central confirmation.
• No prior systemic treatment for metastatic NSCLC.
• Substudy 02: All Experimental arms
• Stage IV NSCLC.
• In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration.

You may not qualify if:

• All Substudies:
• Mixed small-cell lung cancer and NSCLC histology.
• Active second malignancy.
• Active autoimmune disease.
• History of or current non-infectious pneumonitis/interstitial lung disease.
• Active serious infection within 4 weeks prior to study treatment.
• Substudy 01 and 02
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Received previous anticancer therapy within 4 weeks prior to enrollment.
• Substudy 03: All Experimental arms
• NSCLC previously treated with systemic therapy or radiotherapy.
• Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs).

Sponsors & Collaborators

• Gilead Sciences: lead
• Arcus Biosciences, Inc.: collaborator

Study Sites (100)

Arizona Oncology Associates,Substudy-01

Tucson, Arizona, 85711, United States

WITHDRAWN

Arizona Oncology Associates,Substudy-02

Tucson, Arizona, 85711, United States

COMPLETED

Rocky Mountain Cancer Center,Substudy-01

Denver, Colorado, 80218, United States

WITHDRAWN

Rocky Mountain Cancer Center,Substudy-02

Denver, Colorado, 80218, United States

WITHDRAWN

Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03

Fort Wayne, Indiana, 46845, United States

RECRUITING

Baptist Health Lexington,Substudy-03

Lexington, Kentucky, 40503, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center,Substudy-01

St Louis, Missouri, 63110, United States

ACTIVE NOT RECRUITING

Washington University School of Medicine - Siteman Cancer Center,Substudy-02

St Louis, Missouri, 63110, United States

ACTIVE NOT RECRUITING

Washington University School of Medicine - Siteman Cancer Center,Substudy-03

St Louis, Missouri, 63110, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

Oncology Hematology Care Clinical Trials, LLC,Substudy-01

Cincinnati, Ohio, 45242, United States

ACTIVE NOT RECRUITING

Oncology Hematology Care Clinical Trials, LLC,Substudy-02

Cincinnati, Ohio, 45242, United States

ACTIVE NOT RECRUITING

Oncology Associates of Oregon, PC,Substudy-01

Eugene, Oregon, 97401, United States

COMPLETED

Oncology Associates of Oregon, PC,Substudy-02

Eugene, Oregon, 97401, United States

ACTIVE NOT RECRUITING

Texas Oncology - Central South,Substudy-01

Austin, Texas, 78745, United States

WITHDRAWN

Texas Oncology - Central South,Substudy-02

Austin, Texas, 78745, United States

WITHDRAWN

US Oncology Investigational Products Center (IPC),Substudy-01

Fairfax, Virginia, 22031, United States

WITHDRAWN

US Oncology Investigational Products Center (IPC),Substudy-02

Fairfax, Virginia, 22031, United States

WITHDRAWN

Fred Hutchinson Cancer Center,Substudy-01

Seattle, Washington, 98109, United States

WITHDRAWN

Fred Hutchinson Cancer Center,Substudy-02

Seattle, Washington, 98109, United States

WITHDRAWN

Fundação Pio XII - Hospital de Amor,Substudy-01

Barretos, 14784-400, Brazil

RECRUITING

Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03

Porto Alegre, 90110-270, Brazil

RECRUITING

Hospital Mae de Deus,Substudy-01

Porto Alegre, 90110-270, Brazil

RECRUITING

Hospital Mae de Deus

Porto Alegre, 90110-270, Brazil

RECRUITING

Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01

Porto Alegre, 90610001, Brazil

RECRUITING

Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03

Porto Alegre, 90610001, Brazil

RECRUITING

BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01

São Paulo, 1509, Brazil

RECRUITING

Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01

São Paulo, 1509, Brazil

RECRUITING

Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03

São Paulo, 1509, Brazil

RECRUITING

Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03

São Paulo, 1509, Brazil

RECRUITING

Queen Mary Hospital,Substudy-01

Hong Kong, 999077, Hong Kong

RECRUITING

Queen Mary Hospital,Substudy-02

Hong Kong, 999077, Hong Kong

ACTIVE NOT RECRUITING

Queen Elizabeth Hospital,Substudy-01

Hong Kong, Hong Kong

RECRUITING

Queen Elizabeth Hospital,Substudy-02

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Prince of Wales Hospital,Substudy-01

New Territories, Hong Kong

RECRUITING

Prince of Wales Hospital,Substudy-02

New Territories, Hong Kong

ACTIVE NOT RECRUITING

Rambam Health Care Campus,Substudy-01

Haifa, 3525408, Israel

RECRUITING

Rambam Health Care Campus,Substudy-02

Haifa, 3525408, Israel

ACTIVE NOT RECRUITING

Rambam Health Care Campus,Substudy-03

Haifa, 3525408, Israel

RECRUITING

Shaare Zedek Medical Center,Substudy-01

Jerusalem, 9103102, Israel

RECRUITING

Shaare Zedek Medical Center,Substudy-02

Jerusalem, 9103102, Israel

ACTIVE NOT RECRUITING

Shaare Zedek Medical Center,Substudy-03

Jerusalem, 9103102, Israel

RECRUITING

Hadassah Medical Center,Substudy-01

Jerusalem, 91120, Israel

RECRUITING

Hadassah University Medical Center,Substudy-03

Jerusalem, 91120, Israel

RECRUITING

Rabin Medical Center,Substudy-03

Petah Tikva, 49100, Israel

WITHDRAWN

Tel Aviv Sourasky Medical Center,Substudy-01

Tel Aviv, 64239, Israel

RECRUITING

Tel Aviv Sourasky Medical Center,Substudy-02

Tel Aviv, 64239, Israel

ACTIVE NOT RECRUITING

Tel-Aviv Sourasky Medical Center,Substudy-03

Tel Aviv, 64239, Israel

RECRUITING

Chungbuk National University Hospital,Substudy-01

Cheongju-si, 28644, South Korea

ACTIVE NOT RECRUITING

Chungbuk National University Hospital,Substudy-02

Cheongju-si, 28644, South Korea

ACTIVE NOT RECRUITING

National Cancer Center,Substudy-01

Goyang, 410769, South Korea

RECRUITING

National Cancer Center,Substudy-02

Goyang, 410769, South Korea

ACTIVE NOT RECRUITING

National Cancer Center,Substudy-03

Goyang, 410769, South Korea

RECRUITING

Chonnam National University Hwasun Hospital,Substudy-01

Gwangju, 61469, South Korea

RECRUITING

Chonnam National University Hwasun Hospital,Substudy-03

Gwangju, 61469, South Korea

RECRUITING

Seoul National University Bundang Hospital,Substudy-01

Gyeonggi-do, 463-707, South Korea

RECRUITING

Seoul National University Bundang Hospital,Substudy-03

Gyeonggi-do, 463-707, South Korea

RECRUITING

Kosin University Gospel Hospital,Substudy-01

Seogu, 49267, South Korea

ACTIVE NOT RECRUITING

Kosin University Gospel Hospital,Substudy-03

Seogu, 49267, South Korea

ACTIVE NOT RECRUITING

Severance Hospital, Yonsei University Health System,Substudy-03

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center,Substudy-02

Seoul, 05505, South Korea

ACTIVE NOT RECRUITING

Asan Medical Center,Substudy-03

Seoul, 05505, South Korea

RECRUITING

Asan Medical Centre,Substudy-01

Seoul, 05505, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center,Substudy-01

Seoul, 06351, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center,Substudy-02

Seoul, 06351, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center,Substudy-03

Seoul, 06351, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System,Substudy-01

Seoul, 120-752, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System,Substudy-02

Seoul, 120-752, South Korea

ACTIVE NOT RECRUITING

Seoul National University,Substudy-01

Seoul, 463-707, South Korea

WITHDRAWN

Seoul National University,Substudy-02

Seoul, 463-707, South Korea

ACTIVE NOT RECRUITING

Korea University Guro Hospital,Substudy-01

Seoul, 8308, South Korea

ACTIVE NOT RECRUITING

Korea University Guro Hospital,Substudy-03

Seoul, 8308, South Korea

RECRUITING

Changhua Christian Hospital,Substudy-01

Changhua, 500-06, Taiwan

RECRUITING

Changhua Christian Hospital,Substudy-02

Changhua, 500-06, Taiwan

ACTIVE NOT RECRUITING

Changhua Christian Hospital,Substudy-03

Changhua, 500-06, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01

Kaohsiung City, 80756, Taiwan

ACTIVE NOT RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02

Kaohsiung City, 80756, Taiwan

ACTIVE NOT RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03

Kaohsiung City, 80756, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital,Substudy-01

Kaohsiung City, 83301, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital,Substudy-02

Kaohsiung City, 83301, Taiwan

ACTIVE NOT RECRUITING

Kaohsiung Chang Gung Memorial Hospital,Substudy-03

Kaohsiung City, 83301, Taiwan

RECRUITING

National Taiwan University Hospital,Substudy-01

Taipei, 100, Taiwan

RECRUITING

National Taiwan University Hospital,Substudy-02

Taipei, 100, Taiwan

ACTIVE NOT RECRUITING

Adana City Training and Research Hospital,Substudy-01

Adana, 01120, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hastanesi,Substudy-01

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hospital,Substudy-03

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Medical Park Samsun,Substudy-01

Atakum, 55200, Turkey (Türkiye)

RECRUITING

Dicle University,Substudy-01

Diyarbakır, 21100, Turkey (Türkiye)

RECRUITING

Dicle University Medical Faculty,Substudy-03

Diyarbakır, 21280, Turkey (Türkiye)

RECRUITING

Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01

Konya, 42080, Turkey (Türkiye)

RECRUITING

Necmettin Erbakan Universitesi,Substudy-03

Meram Konya, 42080, Turkey (Türkiye)

RECRUITING

Gazi University Medical Faculty,Substudy-01

Yenimahalle, Turkey (Türkiye)

RECRUITING

Gazi University Medical Faculty,Substudy-03

Yenimahalle, Turkey (Türkiye)

RECRUITING

Birmingham Heartlands Hospital,Substudy-03

Birmingham, B9 5SS, United Kingdom

ACTIVE NOT RECRUITING

University Hospitals Birmingham NHS Trust,Substudy-01

Birmingham, B9 5SS, United Kingdom

ACTIVE NOT RECRUITING

University Hospitals Birmingham NHS Trust,Substudy-02

Birmingham, B9 5SS, United Kingdom

ACTIVE NOT RECRUITING

St James University Hospital,,Substudy-01

Leeds, LS9 7TF, United Kingdom

RECRUITING

St. Bartholomew's Hospital,Substudy-01

London, E1 1BB, United Kingdom

RECRUITING

St. Bartholomew's Hospital,Substudy-02

London, E1 1BB, United Kingdom

ACTIVE NOT RECRUITING

St. Bartholomew's Hospital,Substudy-03

London, E1 1BB, United Kingdom

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

zimberelimab; sacituzumab govitecan; Carboplatin; Cisplatin; Pemetrexed; Paclitaxel; 130-nm albumin-bound paclitaxel; Docetaxel; Nivolumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: March 16, 2023
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); TU (10); GB (7); HK (6); TW (11); KR (24); IL (12); BR (10)