A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)

NCT07066098 | Recruiting Phase 3 DMC

• 1 other identifier: CIBI343B302
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival(OS)

  Overall survival (OS) is defined as the time from randomization to death from any cause.

  approximately 24 months

Secondary Outcomes (10)

• progression free survival(PFS)

  approximately 24 months

• Objective response rate (ORR)

  approximately 24 months

• disease control rate (DCR)

  approximately 24 months

• duration of response (DoR)

  approximately 24 months

• time to response (TTR)

  approximately 24 months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

IBI343

Drug: IBI343

Control Arm

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IBI343 DRUG

Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle

Experimental Arm

Placebo DRUG

Subjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle

Control Arm

Eligibility Criteria

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

You may qualify if:

• Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan.
• Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer.
• Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy).
• ECOG PS score of 0 or 2.
• Adequate bone marrow and organ function
• Confirmed as CLDN18.2 positive.

You may not qualify if:

• Participation in another interventional study, except observational or post-intervention follow-up.
• Prior treatment with topoisomerase inhibitor-based ADC.
• Has received the last dose of an anti-cancer therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
• Plans to receive other anti-tumor treatments during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed) .
• Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria.
• History of other primary malignancies, except cured or low-risk of recurrence.

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Penglei Zheng

CONTACT

86-512-69566088; penglei.zheng@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 15, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)