A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors

NCT06730386 | Recruiting Phase 1 DMC

• 1 other identifier: AK138D1-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.

Conditions

Solid Cancer

Outcome Measures

Primary Outcomes (2)

• AEs

  Incidence and severity of participants with adverse events

  Up to approximately 2 years

• Dose-limiting toxicity (DLT)

  Occurrence of DLTs and determination fo maximum tolerated dose (MTD)

  Up to approximately 2 years

Secondary Outcomes (8)

• Cmax and Cmin of AK138D1

  Up to approximately 2 years

• Anti-drug antibodies (ADA)

  Up to approximately 2 years

• Objective Response Rate (ORR) assessed by investigator per RECIST v1.1

  Up to approximately 2 years

• Disease Control Rate (DCR) assessed by investigator per RECIST v1.1

  Up to approximately 2 years

• Duration of response (DoR) assessed by the investigator per RECIST v1.1

  Up to approximately 2 years

Study Arms (1)

AK138D1

EXPERIMENTAL

AK138D1 will be administered in pre-specified dose levels.

Drug: AK138D1

Interventions

AK138D1 DRUG

Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.

AK138D1

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 subject must sign the written informed consent form (ICF) voluntarily;
• At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
• ECOG performance status score of 0 or 1;
• Has a life expectancy of ≥ 3 months;
• Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;
• At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
• Adequate organ function.

You may not qualify if:

• Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;
• Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
• Presence of active central nervous system (CNS) metastases.
• Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;
• Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
• Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
• Active syphilis infection;
• Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
• Other reasons for ineligibility as evaluated by the investigator.

Sponsors & Collaborators

• Akeso: lead

Study Sites (4)

Blacktown Hospital-Blacktwon Cancer and Haematology Centre

Blacktown, New South Wales, 2148, Australia

NOT YET RECRUITING

Macquarie University

North Ryde, New South Wales, 2109, Australia

NOT YET RECRUITING

ICON Cancer Centre South Brisbane

South Brisbane, Queensland, 4101, Australia

RECRUITING

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

RECRUITING

Central Study Contacts

Wenting Li, MD

CONTACT

+86-18116403289; wenting01.li@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: December 9, 2024
• First Posted: December 12, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): February 26, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

AU (4)