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A Study of KM501 in Patients With Solid Tumors

NCT05804864 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-04-07

No results posted yet for this study

Summary

A single-arm, open, multicenter Phase I study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the KM501 double-antibody ADC in subjects with advanced solid tumors that express, amplify, or mutate HER2

Conditions

Interventions

DRUG

KM501

1a: The program evaluated six dose levels, i.e., 0.1, 0.3, 0.6, 1.2, 1.8, 2.4 mg/kg, An accelerated titration was performed in the 0.1 and 0.3 mg/kg dose groups, and then a Bayesian optimal interval design was used to determine MTDS for four subsequent dose levels. Ib: The antitumor activity of KM501 monotherapy in subjects with specific types of tumors that are HER2-positive or express, amplify, or mutate will be evaluated at the RP2D dose level

Sponsors & Collaborators

  • Xuanzhu Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yi Ba · Tianjin Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05804864 on ClinicalTrials.gov