XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.

Sponsor
Evopoint Biosciences Inc.
Study ID
NCT06792435
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer
  • Colorectal Cancer Metastatic
  • Gastric Carcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Lung Cancer (NSCLC)
  • Ovarian Cancer
  • Pancreatic Adenocarcinoma Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XNW27011 — DRUG
    Eligible patient(s) in each dose cohort will receive the assigned XNW27011 dose administration every 3 weeks (Q3W, cycle) until intolerable toxicity, progression of the disease without clinical benefit, or withdrawal of informed consent. An accelerated titration scheme will be used for the first two dose levels (0.6 mg/kg and 1.2 mg/kg) starting from 0.6 mg/kg dose as follows: The first patient will be enrolled for 0.6 mg/kg dose. If the subject shows no significant toxicity in cycle 1 (DLT observation period), the second patient will be enrolled for 1.2 mg/kg. 3 + 3 dose escalation:3 patients will be enrolled to the dose cohort first，If 1 of 3 patients experiences a DLT, up to 3 more patients will be enrolled in the same dose cohort.. If none of the additional 3 patients experiences a DLT, dose escalation will continue to the next dose.Dose escalation will be stopped when 2 or more patients out of 3 to 6 patients at the same dose level experience a DLT.
  • XNW27011 — DRUG
    Group A: Gastric/gastroesophageal junction adenocarcinoma with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group B: Pancreatic adenocarcinoma with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group C: Ovarian cancer with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group D: Other tumors with CLDN18.2 expression, including but not limited to esophagus adenocarcinoma, lung cancer, colorectal cancer, and biliary tract cancer,tentatively expand with 3.6, 3.0, 2.4 mg/kg.

Study Details

This is a global, multi-center, open-label, Phase I/II first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and/or metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions. The study consists of 2 parts: Part 1 is the dose-escalation phase (Phase I), and Part 2 is the does-expansion phase (Phase II). In phase I part of the study, approximately 42 patients with locally advanced and/or metastatic solid tumors will be enrolled, irrespective of CLDN18.2 expression. However, the most recently available tumor tissue specimen will be collected (if available) for a retrospective CLDN18.2 expression confirmation. In phase II part of the study, only patients with confirmed CLDN18.2 expression by IHC in the central laboratory will be enrolled.The phase II part of the study will consist of the following four groups，Up to three dose cohorts for each patient group are planned currently. Each dose cohort will include approximately 20 patients. Approximately 240 patients evaluable will be enrolled in Phase Ⅱ part of the study.

Key Dates

First listed
Jan 24, 2025
Start date
Jul 27, 2023
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Escalation
    Based on the preclinical data of XNW27011, the dose-escalation study will start from the initial dose of 0.6 mg/kg. Dose escalation will be performed by using a modified Fibonacci method with a slightly fine-tuned dose escalation amplitude. The first two dose escalations will be by 100% of the preceding dose and thereafter by 50%, 33%, 25% and 25% of the preceding doses. Therefore, there are 7 dose cohorts for projected dose escalations as follows
  • Experimental: Phase II: Expanded cohorts
    The SRC will select up to 3 recommended doses for Phase II study based on the safety, PK, ADA and preliminary efficacy data from Phase I study (dose escalation). Phase Ⅱwill include 4 patient groups, and up to 3 dose cohorts for each patient group. Approximately 20 Chinese or U.S. patients will be enrolled to each dose cohort with an approximately total of 240 patients in the Phase II study to further evaluate the antitumor activity, safety, tolerability, PK and incidence of ADA for XNW27011.

Primary Outcome Measure

Phase I (Dose Escalation):To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of XNW27011 [ Time Frame: Baseline up to approximately 2 years ]

Central Contacts

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