A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety and Efficacy of ANO31905 for Injection in Combination With Chemotherapy as the First-line Treatment for Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Study Identifier:
ANO31905-204
CT.gov Identifier:
NCT07444541
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Pancreas
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: ANO31905 (high dose) plus GEM+Nab-P
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Drug: Drug: ANO31905
Drug: ANO31905: If the lower dose is tolerated, a higher dose of 800 μg/kg will be administered to the subjects. ANO31905 will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
Drug: Drug: Gemcitabine
Drug: 1000 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).
Drug: Drug: Nanoparticle Albumin-Bound Paclitaxel
Drug: 125 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).
Drug: EXPERIMENTAL: ANO31905 (low dose) plus GEM+Nab-P
Drug: The initial dose is 500 μg/kg Q2W. The drug will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • 1. Males or females aged ≥ 18 at the time of signing the ICF;
  • 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  • 3. Expected survival ≥ 3 months;
  • 4. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
  • 5. At least one measurable lesion according to RECIST v1.1;
  • 6. Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory;
  • 7. Patients with sufficient organ function within 7 days before the first study dose;
  • 8. Non-pregnant or -lactating women.
Exclusion criteria
  • 1. Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment; Any previous systematic anti-cancer therapy
  • 2. Any previous systematic anti-cancer therapy;
  • 3. Previous treatment targeting CLDN18.2;
  • 4. Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;
  • 5. Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;
  • 6. Patients with known metastases to the central nervous system;
  • 7. Patients with severe cardiovascular and cardiovascular diseases;
  • 8. Presence risks of thrombosis or bleeding;
  • 9. Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment;
  • 10. Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;
  • 11. Patients with other conditions that may place the patients at increased undue study-related risks.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Neel Belani
Status
Will Be Recruiting
Condition(s) Treated at Site
Pancreas
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Sreenivasa Chandana
Status
Will Be Recruiting
Condition(s) Treated at Site
Pancreas
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Will Be Recruiting
Condition(s) Treated at Site
Pancreas