Clinical trial NCT06238843: A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma
Official title: A Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)


Eligibility criteria: Inclusion Criteria:

1. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.
2. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
3. Has received and progressed on at least 2 lines of systemic therapy (anti-PD-(L)1 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. The subject has ≤ 4 prior lines of systemic therapy.
4. Has histopathologically confirmed CLDN18.2-positive disease.
5. Is a man or woman of 18 years of age or older at the time of signing the ICF.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Exclusion Criteria:

1. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease.
2. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
3. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).
4. Has received the last dose of an anti-cancer therapy (including traditional Chinese medicine indicated for gastric cancer in the package insert, but excluding herbal prescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
5. Plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed).

Primary outcomes:
measure: progression free survival(PFS)
timeFrame: within approximately 20 months
measure: overall survival(OS)
timeFrame: within approximately 26 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: within approximately 20 months
measure: disease control rate (DCR)
timeFrame: within approximately 20 months
measure: duration of response (DoR)
timeFrame: within approximately 20 months
measure: time to response (TTR)
timeFrame: within approximately 20 months
measure: area under the curve (AUC)
timeFrame: within approximately 20 months
measure: maximum concentration (Cmax)
timeFrame: within approximately 20 months
measure: time to maximum concentration(Tmax)
timeFrame: within approximately 20 months
measure: trough concentration (Ctrough)
timeFrame: within approximately 20 months
measure: clearance (CL)
timeFrame: within approximately 20 months
measure: volume of distribution (V)
timeFrame: within approximately 20 months
measure: Incidence of anti-drug antibody (ADA)
timeFrame: within approximately 20 months
measure: neutralizing antibody (NAb)
timeFrame: within approximately 20 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: