A Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of AK132 in Advanced Malignant Solid Tumor

NCT06166472 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: AK132-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 7

Brief Summary

This is A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor

Conditions

Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (2)

• dose-limiting toxicity （DLT）、adverse event（AE）、serious adverse event（SAE）

  incidence and severity of DLT, adverse events (AE), serious adverse events (SAE)

  Up to 2 years

• Maximum tolerated dose (MTD),RP2D

  Maximum tolerated dose (MTD), Recommended dose for phase II trial

  Up to 2 years

Secondary Outcomes (8)

• Pharmacokinetic

  Up to 2 years

• Immunogenicity assessmen

  Up to 2 years

• Objective response rate (ORR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

Study Arms (1)

AK132

EXPERIMENTAL

Each subject will receive a single dose of AK132 every 2-week cycle (Q2W).

Drug: AK132

Interventions

AK132 DRUG

IV infusion, specified dose on specified days.

AK132

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
• Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
• Histologically and/or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors.
• The interval between the end of the last systemic anti-tumor treatment and the first dose should be at least 3 weeks.
• Subjects in the dose expansion phase are required to provide tumor tissue samples.
• At least one measurable tumor lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 3 months.
• Adequate organ function as assessed in the laboratory tests.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Male patients with female partners of childbearing potential must agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.

You may not qualify if:

• There is active or untreated brain metastases,Meningeal metastases, spinal cord compression, or leptomeningeal disease.
• Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
• Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
• gastrointestinal perforation or gastrointestinal fistula within 6 months before the first dose.
• clinically significant bleeding symptoms or a clear tendency to bleed within 4 weeks before the first dose.
• Active malignant tumors within the past 3 years, except for tumors in this study and scured local tumors.
• History of hemolytic anemia due to any cause within 3 months before the first dose of study drug.
• Have a history of defects in red blood cell or hemoglobin production or metabolism.
• Major surgery other than the diagnosis of solid tumors within 28 days prior to the first dose or major surgery is expected during the study.
• Clinically significant cardiovascular or cerebrovascular disease.
• Presence of ≥ Grade 2 peripheral neuropathy as defined by NCI CTCAE v5.0.
• Presence of active diverticulitis.
• Patients with serious neurological or psychiatric disorders.
• Pregnant or lactating women.
• Patients who received palliative local therapy for any tumor lesions within 2 weeks prior to the first dose;and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to the first dose.

Sponsors & Collaborators

• Akeso: lead

Study Sites (7)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350000, China

Location

Sun Yat-Sen University Cancer Center, Guangzhou, China

Guangzhou, Guangdong, 510060, China

Location

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, 510080, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510220, China

Location

Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

Wuhan, Hubei, 430000, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441100, China

Location

Hunan Provincial Cancer Hospital

Changsha, Hunan, 410000, China

Location

Study Officials

• Ruihua Xu, M.D.

  Name:Sun Yat-Sen University Cancer Center, Guangzhou, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifang Yao, M.D.

CONTACT

+86-0760-89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 12, 2023
• Study Start: December 12, 2023
• Primary Completion: April 24, 2026
• Study Completion: July 24, 2026
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)