Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers

NCT05043987 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: CPO102-US-1001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available.

Conditions

Pancreatic Cancer; Gastric Cancer

Keywords

Claudin 18.2 ADC; Phase 1; CPO102; Pancreatic Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period.

  DLTs are assessed during the first cycle (21 days) in each cohort to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

  through study completion, an average of 3 year

Secondary Outcomes (10)

• Number of participants with treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship.

  through study completion, an average of 3 year

• Number of participants with clinically significant changes in vital signs

  through study completion, an average of 3 year

• Number of participants with clinically significant changes in clinical laboratory tests

  through study completion, an average of 3 year

• CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval.

  through study completion, an average of 3 year

• CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax)

  through study completion, an average of 3 year

Study Arms (3)

Part A

EXPERIMENTAL

Part A will follow the standard 3+3 dose-escalation design and will be enrolled at dose levels of CPO102 at (0.5, 1, 1.8, 2.5, 3.5, 4.5, 5.5 mg/kg). Each subject group will receive one dose of CPO-102 every 3 weeks (1 cycle=21 days=1 treatment). For each cohort, the decision whether to dose-escalate will be made once all patients have been enrolled into the cohort and the last patient enrolled has been followed for 21 days (3-week DLT observation period).

Drug: CPO102

Part B-Arm 1

EXPERIMENTAL

Upon attaining a RP2D, Part B-Arm 1 will include approximately 15 patients with pancreatic cancer patients. This subject group will receive multiple cycles of a weekly dose of CPO-102 (1 cycle=21 days=1 treatment).

Drug: CPO102

Part B-Arm 2

EXPERIMENTAL

Upon attaining a RP2D, Part B-Arm 2 will include approximately 15 gastric (including gastric esophageal junction) cancer patients. This subject group will receive multiple cycles of a weekly dose of CPO-102 (1 cycle=21 days=1 treatment).

Drug: CPO102

Interventions

CPO102 DRUG

Anti-claudin 18.2 Antibody-MMAE Drug Conjugate

Part A; Part B-Arm 1; Part B-Arm 2

Eligibility Criteria

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

You may qualify if:

• Applicable to all patients in both Part A and Part B of the study:
• Pathological diagnosis (histological) of pancreatic or gastric including esophageal junction cancers.
• Patient must provide archived tissue block or formalin-fixed paraffin-embedded (FFPE) slides or fresh biopsy prior to start of treatment.
• Positive claudin 18.2 tumor expression defined as ≥50% of tumor cells demonstrating moderate-to-strong membranous staining (2+/3+) by IHC assay performed on sections of tumor derived from formalin fixed paraffin block.
• Adequate organ function.
• Life expectancy \>12 weeks.
• Age ≥18 years.
• ECOG performance status 0 or 1 at screening.
• Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent.
• Patients of reproductive potential: All female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before study entry.
• Specific criteria for Part A:
• Disease progression or relapse following conventional chemotherapy:
• Pancreatic cancer
• Gastric cancer (including GEJ cancer)
• Specific criteria for Part B:

You may not qualify if:

• Patient has participated in any investigational research study and is being screened for participation within a period of 5 half-lives or 4 weeks, whichever is longer, of the last dose of the investigational therapy.
• History of severe infusion reaction with monoclonal antibody treatment.
• Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening.
• HIV positive test within 8 weeks of screening.
• Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• Presence of other active cancers, or history of treatment for invasive cancer ≤3 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (ie, noninvasive) are eligible, as are patients with history of nonmelanoma skin cancer.
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
• Active central nervous system (CNS) disease involvement, defined by cerebrospinal fluid (CSF) cytology, magnetic resonance imaging (MRI) or computerized tomography (CT); patients with asymptomatic CNS metastases are eligible if participants have been clinically stable for at least 4 weeks prior to the first dose of study drug and do not require interventions such as surgery, radiation or any corticosteroid therapy for management of symptoms related to CNS disease.
• Peripheral neuropathy Grades ≥ 2.
• Active ocular surface disease at baseline (based on ophthalmic evaluation).
• Pregnant or nursing (lactating) women.
• Patients who received claudin 18.2 targeting agents previously.
• Patients who have received or will receive coronavirus disease 2019 (COVID-19) vaccine within 72 hours prior to the first dose of study drug.
• Prior radiotherapy

Sponsors & Collaborators

• Conjupro Biotherapeutics, Inc.: lead
• CSPC Megalith Biopharmaceutical Co.,Ltd.: collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiangfeng Su, MD, PhD

  Conjupro Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 14, 2021
• Study Start: November 16, 2022
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share