A Study of IBI363 in Subjects With Advanced Malignancies

NCT06468098 | Recruiting Phase 1

• 1 other identifier: CIBI363A103
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter Phase Ib study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced malignancies patients

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (10)

• Adverse Enent (AE)

  Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

  Up to 90 days after the last administration

• Treatment-Emergent AE (TEAE)

  Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

  Up to 90 days after the last administration

• Adverse Event of Special Interest (AESI)

  Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

  Up to 90 days after the last administration

• Serious Adverse Event (SAE)

  Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

  Up to 90 days after the last administration

• Objective response rate (ORR)

  ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR).

  Through out the study (up to 2 years)

• disease control rate (DCR)

  DCR is defined as the proportion of participants with a complete response (CR) or partial response (PR) or stable disease(SD)

  Through out the study (up to 2 years)

• time to response (TTR)

  TTR is defined as the time from the date of first dose of study drug to the date of first documented tumor response (CR/PR)

  Through out the study (up to 2 years)

• duration of response (DoR)

  DoR is defined as the time from the date of first documented tumor response (CR/PR) until PD/death

  Through out the study (up to 2 years)

• progression-free survival (PFS)

  PFS is defined as the time from the date of first dose of study drug to the date of the first documented progression or death due to any cause, whichever occurs first

  Through out the study (up to 2 years)

• Overall survival (OS)

  OS is defined as the time from the date of first dose of study drug until the date of death from any cause.

  Through out the study (an average of 2 years)

Secondary Outcomes (6)

• Plasma concentration (Cmax) of IBI363

  Up to 2 years

• Area under the curve (AUC) of IBI363

  Up to 2 years

• Half-life (T1/2) of IBI363

  Up to 2 years

• Clearance (CL) of IBI363

  Up to 2 years

• Volume of distribution (V) of IBI363

  Up to 2 years

Study Arms (9)

Cohort 1

EXPERIMENTAL

IBI363 combined with chemotherapy in patients with advanced NSCLC who have failed at least one prior line of standard therapy (which needs to include immunotherapy)

Drug: IBI363 + chemotherapy

Cohort 2A

EXPERIMENTAL

IBI363 combined with chemotherapy as first-line in patients with advanced colorectal cancer, including a safety run-in phase and a randomized controlled phase

Drug: IBI363 + chemotherapy

Cohort 2B

EXPERIMENTAL

IBI363 combined with chemotherapy as first-line in patients with advanced colorectal cancer, including a safety run-in phase and a randomized controlled phase

Drug: IBI363 + chemotherapy

Cohort 3

EXPERIMENTAL

IBI363 combined with chemotherapy in patients with advanced biliary tract tumors that have failed or are intolerant to first-line standard therapy

Drug: IBI363 + chemotherapy

Cohort 4

EXPERIMENTAL

IBI363 combined with chemotherapy in second-line in patients with Advanced Esophageal Squamous Cell Carcinoma

Drug: IBI363 + chemotherapy

Cohort 5

EXPERIMENTAL

IBI363 combined with chemotherapy in second-line in patients with Advanced Gastric Cancer

Drug: IBI363 + chemotherapy

Cohort 6

EXPERIMENTAL

IBI363 combined with chemotherapy in patients with Advanced Triple-Negative Breast Cancer

Drug: IBI363 + chemotherapy

Cohort 7

EXPERIMENTAL

IBI363 combined with chemotherapy in patients with platinum-resistant ovarian cancer that has failed or is intolerant to standard therapy

Drug: IBI363 + chemotherapy

Cohort 8

EXPERIMENTAL

IBI363 Combined with Investigator's Choice Standard of Care(SOC) in Patients with Advanced Solid Tumors

Drug: IBI363 + Investigator's Choice SOC

Interventions

IBI363 + chemotherapy DRUG

In this group, patients will receive IBI363 and chemotherapy

Cohort 1; Cohort 2A; Cohort 2B; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

IBI363 + Investigator's Choice SOC DRUG

In this group, patients will receive IBI363 and Investigator's Choice SOC

Cohort 8

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
• Male or female subjects, age 18\~75 years.
• Histologically or cytologically confirmed advanced malignancy.
• Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy. For particular cohort, subjects who have not received prior systemic therapy for advanced disease.
• At least one measurable lesion (target lesion) per RECIST v1.1.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Life expectancy of 3 months or more.
• Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.

You may not qualify if:

• Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
• Active or untreated CNS metastases confirmed by imaging evaluation during screening or previous imaging evaluation. Patients with asymptomatic brain metastases may participate in this study.
• History of active thrombosis or deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug.
• Clinically significant cardiovascular or cerebrovascular disease.
• Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.
• History of allergies, asthma, atopic dermatitis.
• Concomitant pleural or pericardial effusion requiring repeated drainage or with significant symptoms.
• Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Subjects with known or suspected hypersensitivity to the study drug and any excipients.
• Subject has a prior history of significant toxicity associated with immune checkpoint inhibitor administration that requires permanent discontinuation.
• Subjects with unresolved \> Grade 1 toxicity associated with any prior antineoplastic therapy, with the exception of persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, and toxicities that are not expected to be reversible but are stably controlled by medications (e.g., hypothyroidism stably controlled by substitution therapy, hypertension stably controlled by antihypertensive medications with a BP of less than 160/100 mmHg).
• Inadequate recovery from previous surgery or any major surgery within 4 weeks prior to the first dose of study drug.
• Active uncontrolled bleeding or known bleeding tendency.
• Subject has a current or recent (within 6 months) major gastrointestinal disease or condition.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai Chest Hospita

Shanghai, Shanghai Municipality, 20030, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• tingbo Liang, M.D.

  The First Affiliated Hospital ZJ University

  PRINCIPAL INVESTIGATOR

• xueli Bai, M.D.

  The First Affiliated Hospital ZJ University

  PRINCIPAL INVESTIGATOR

• jianming Xu, M.D.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• shun Lu, M.D.

  Shanghai Chest Hospita

  PRINCIPAL INVESTIGATOR

• tao Zhang, M.D.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

binbin Min

CONTACT

0512-69566088; bingo.min@innoventbio.com

Study Design

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

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 21, 2024
• Study Start: June 15, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)