A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors
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.
Study details:
This study is comprised of two parts: the dose-escalation and dose-expansion stages. Dose-escalation stage aims to determine the MTD/MAD, while the dose-expansion stage is designed to establish the RP2D.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion.
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06730386
Intervention or treatment
DRUG: AK138D1
Conditions
- Solid Cancer
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Research sites nearby
Closest Location:
Blacktown Hospital-Blacktwon Cancer and Haematology Centre
Select from list below to view details:
Blacktown Hospital-Blacktwon Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
ICON Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
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Who is running the clinical trial?
Akeso
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: AK138D1
| Drug: AK138D1 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and Cmin of AK138D1 | AK138D1 serum drug concentrations in subjects at different time points after administration. | Up to approximately 2 years |
| Anti-drug antibodies (ADA) | Number of subjects with detectable anti-drug antibodies (ADA). | Up to approximately 2 years |
| Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1. | Up to approximately 2 years |
| Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 | Disease control rate (DCR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| Duration of response (DoR) assessed by the investigator per RECIST v1.1 | Duration of response (DoR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| Time to response (TTR) assessed by the investigator per RECIST v1.1 | Time to response (TTR) is defined as the time to response based on RECIST v1.1. | Up to approximately 2 years |
| Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 | PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from randomization to death due to any cause. | Up to approximately 2 years |
References
Clinical Trials Gov: A Phase I Study of AK138D1 in the Treatment of Advanced Solid TumorsOther trials to consider
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