A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors

NCT04991740 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1090282021-001646-3578306358STM1001
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to determine the recommended phase 2 dose (RP2D) regimen(s) of JNJ-78306358 in Part 1 (Dose Escalation) and to determine the safety of JNJ-78306358 at the RP2D regimen(s) in Part 2 (Dose Expansion).

Conditions

Neoplasms

Keywords

Kidney cancer; Ovarian cancer; Colorectal cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Incidence of Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 2 years and 4 months

• Number of Participants with AEs by Severity

  Number of participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events, which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  Up to 2 years and 4 months

• Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

  Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  Up to 21 days

Secondary Outcomes (7)

• Maximum Serum Concentration (Cmax) of JNJ-78306358

  Up to 2 years and 4 months

• Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-78306358

  Up to 2 years and 4 months

• Area Under the Serum Concentration-time Curve From Time t1 to t2 (AUC[t1-t2]) of JNJ-78306358

  Up to 2 years and 4 months

• Accumulation Ratio (RA) of JNJ-78306358

  Up to 2 years and 4 months

• Number of Participants with Anti-JNJ-78306358 Antibodies

  Up to 2 years and 4 months

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Participants with renal cell carcinoma (RCC), ovarian cancer, colorectal cancer (CRC), and other tumor types with sponsor approval will receive JNJ-78306358. The dose will be escalated sequentially based on the decisions of the study evaluation team until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

Drug: JNJ-78306358

Part 2: Dose Expansion

EXPERIMENTAL

Participants with RCC, ovarian cancer, CRC and other types of tumors will receive JNJ-78306358 at the RP2D regimen(s) determined in Part 1.

Drug: JNJ-78306358

Interventions

JNJ-78306358 DRUG

JNJ-78306358 will be administered.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed, metastatic or unresectable solid tumor of one of the following types:
• a. Renal Cell Carcinoma (RCC): clear cell or papillary carcinoma, b. ovarian cancer: high grade serous epithelial ovarian; primary peritoneal or fallopian tube cancer; 1. low grade or non-serous histologies are not allowed; c. colorectal cancer (CRC); d. other tumor types (including lung adenocarcinoma, endometrial cancer, and pancreas cancer) may be enrolled with sponsor approval
• Measurable or evaluable disease: a. Part 1: either measurable or evaluable disease; b. Part 2: at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per RECIST version1.1 (example ascites) or have Cancer antigen 125 (CA 125) greater than (\>) 2\*upper limit of normal (ULN) within 2 weeks prior to first dose of study drug
• Progressed during or after the following prior therapies for metastatic disease, unless participant was ineligible to receive them: a) RCC: clear cell histology: an antiangiogenic agent and an immune checkpoint inhibitor, administered as 1 or more lines of therapy. For papillary renal carcinoma 1 line of systemic therapy; b. CRC: at least 2 lines of therapy including a fluoropyrimidine, oxaliplatin, and irinotecan given with or without antiangiogenic therapies or epidermal growth factor receptor (EGFR) antibodies. In addition, prior treatment with anti-programmed cell death protein 1 (PD1) antibody is required for high microsatellite instability (MSI-H) CRC; c. ovarian cancer: at least 2 lines of therapy, including at least 1 line with platinum. Maintenance therapy after completion of platinum-containing regimen, example with bevacizumab or a poly- Adenosine di-phosphate (ADP) ribose polymerase inhibitor will not count as a separate line of therapy; d. other tumor types: at least 2 lines of systemic therapy
• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
• Selected participants in pharmacokinetics/pharmacodynamic (PK/PD) cohorts and in Part 2 must agree to undergo the mandatory tumor biopsies

You may not qualify if:

• Active central nervous system involvement
• Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
• Clinically significant pulmonary compromise
• Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
• Solid organ or bone marrow transplantation

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Rambam Medical Center

Haifa, 31096, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Hosp. Univ. Vall D Hebron

Barcelona, 8035, Spain

Location

Hosp. Univ. Fund. Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Univ. Hm Sanchinarro

Madrid, 28050, Spain

Location

Related Publications (1)

• Geva R, Vieito M, Ramon J, Perets R, Pedregal M, Corral E, Doger B, Calvo E, Bardina J, Garralda E, Brown RJ, Greger JG, Wu S, Steinbach D, Yao TS, Cao Y, Lauring J, Chaudhary R, Patel J, Patel B, Moreno V. Safety and clinical activity of JNJ-78306358, a human leukocyte antigen-G (HLA-G) x CD3 bispecific antibody, for the treatment of advanced stage solid tumors. Cancer Immunol Immunother. 2024 Aug 6;73(10):205. doi: 10.1007/s00262-024-03790-7.

  PMID: 39105878 DERIVED

MeSH Terms

Conditions

Neoplasms; Kidney Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 5, 2021
• Study Start: October 24, 2021
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

IL (2); ES (3)