Not yet recruiting NCT06691360
AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK137.
- Who it may be relevant to
- Registry conditions: Advanced Malignant Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors
Overview
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.
Interventions
- Drug AK137
IV infusion, specified dose on specified days.
Primary outcome measures
- AEs [Time frame: From time ICF is signed until 90 days after last dose of AK137]
- DLT [Time frame: During the first 28-day of treatment with AK137]
Secondary outcome measures (9)
- Objective Response Rate (ORR) [Time frame: Up to approximately 2 years]
- Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
- Duration of Response (DoR) [Time frame: Up to approximately 2 years]
- Time to response (TTR) [Time frame: Up to approximately 2 years]
- Progression Free Survival (PFS) [Time frame: Up to approximately 2 years]
- Overall Survival (OS) [Time frame: Up to approximately 2 years]
- Cmax of AK137 [Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)]
- Cmin of AK137 [Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)]
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [Time frame: From first dose of study drug through 30 days after last dose of study drug]
Eligibility criteria
Inclusion criteria
- Written and signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Life expectancy ≥3 months.
- Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- Subject must have at least one measurable lesion according to RECIST Version1.1.
- Adequate organ function.
Exclusion criteria
- Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
- Receipt of any anti-CD73, anti-LAG-3 treatment.
- Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required.
- Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels specified in the inclusion/exclusion criteria, except for toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
- Major surgical procedure within 4 weeks prior to the first dose of AK137 or still recovering from prior surgery.
- History of organ transplant.
- Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT06691360 · AK137-101