IBI343 versus placebo for CLDN18.2-positive advanced pancreatic cancer after at least two prior therapies

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>=2 Prior Lines of Therapy

This trial tests whether IBI343 plus best supportive care can help people with CLDN18.2-positive locally advanced or metastatic pancreatic cancer who have had at least two prior treatments live longer than placebo plus best supportive care.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 201 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07066098 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind Phase III trial comparing IBI343 monotherapy plus best supportive care to placebo plus best supportive care in patients with CLDN18.2-positive, locally advanced unresectable or metastatic pancreatic cancer who progressed after at least two systemic therapies. About 201 participants will be enrolled and randomized 2:1 to receive IBI343 or placebo, with treatment and follow-up visits at participating centers. The primary endpoint is overall survival, and patients must have adequate organ function and ECOG performance status within the allowed range. The trial is sponsored by Innovent Biologics and will be conducted at participating oncology centers including Fudan University Shanghai Cancer Center.

Who should consider this trial

Good fit: Adults with histologically confirmed unresectable locally advanced or metastatic pancreatic cancer that is CLDN18.2-positive, who have progressed after at least two prior systemic therapies (including fluorouracil- and gemcitabine-based regimens) and have adequate organ function and performance status, are ideal candidates.

Not a fit: Patients whose tumors are CLDN18.2-negative, who are too frail to meet eligibility requirements, or who need other anti-cancer treatments during study therapy are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, IBI343 could extend survival for patients with CLDN18.2-positive advanced pancreatic cancer who have exhausted standard treatments.

How similar studies have performed: Other agents targeting CLDN18.2 have shown activity in gastrointestinal cancers, but large-scale success specifically in pancreatic cancer has not yet been established.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Participation in another interventional study, except observational or post-intervention follow-up.
2. Prior treatment with topoisomerase inhibitor-based ADC.
3. 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.
4. 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) .
5. Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria.
6. History of other primary malignancies, except cured or low-risk of recurrence.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Penglei Zheng

Conditions: Pancreatic Cancer