A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

NCT05043298 | Completed Phase 1

• 1 other identifier: CIBI360A101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Safety and tolerance

  Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)

  up to 90 days following last dose

• Recommended Phase 2 Dose (RP2D)

  A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data

  up to 21 days following last dose level

Secondary Outcomes (7)

• Efficacy

  Subjects were randomized 6 months and 1 year later

• Pharmacokinetics

  Up to 48 weeks following first dose

• Immunogenicity

  up to 90 days following last dose

• Pharmacokinetics

  Up to 48 weeks following first dose

• Pharmacokinetics

  Clearance（CL）

Study Arms (2)

IBI360

EXPERIMENTAL

Drug: IBI 360 Injection

IBI 360 + Sintilimab

EXPERIMENTAL

Drug: IBI 360 Injection Sintilimab

Interventions

IBI 360 Injection DRUG

IBI 360 dose level of escalation IV Q3W Day 1

IBI360

IBI 360 Injection Sintilimab DRUG

IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1

IBI 360 + Sintilimab

Eligibility Criteria

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

You may qualify if:

• Provide signed informed consent;
• Male or female aged at 18-75 (inclusive) years;
• Expected survival ≥12 weeks;
• ECOG PS score 0 or 1;
• Provide archival or fresh tissues for CLDN18.2 expression analysis;
• Adequate laboratory parameters;
• Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
• Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
• Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors

You may not qualify if:

• The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
• The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
• Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
• The subjects with history of hypersensitivity to the study drug;
• The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
• The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
• The subjects with pyloric obstruction;
• The subjects with active or poorly controlled serious infections

Sponsors & Collaborators

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

Study Sites (1)

Innovent Biologics (suzhou) Co. , Ltd.

Suzhou, Jiangsu, 215000, China

Location

Study Design

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

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: October 27, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)