Clinical trial · Interventional
A Study of AK138D1 in Advanced Malignant Tumors
A Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AK138D1 in Advanced Solid Tumors
NCT07281326CI-TRIAL-00098914recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase I clinical trial testing the safety and effectiveness of AK138D1in patients with advanced cancer. The study will enroll up to 200 patients with various types of advanced solid tumors who haven't responded to standard treatments. Patients will receive AK138D1 to determine the safest dose and evaluate if the drug can help treat their cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Cancer | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK138D1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK138D1
- description
- AK138D1 will be administered in pre-specified dose levels.
- interventionNames
- Drug: AK138D1
Primary outcomes (2)
- measure
- Adverse events (AEs)
- timeFrame
- Up to approximately 2 years
- description
- Incidence and severity of participants with adverse events
- measure
- Dose-Limiting Toxicity (DLT)
- timeFrame
- Up to approximately 2 years
- description
- Occurrence of DLTs and determination fo maximum tolerated dose (MTD)
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject must sign the written informed consent form (ICF) voluntarily; 2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible; 3. ECOG performance status score of 0 or 1; 4. Has a life expectancy of ≥ 3 months; 5. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement. 6. Adequate organ function. Exclusion Criteria: 1. 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; 2. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study; 3. Presence of active central nervous system (CNS) metastases. 4. 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; 5. Untreated subjects with active hepatitis B or active hepatitis C; 6. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease; 7. Known active syphilis infection; 8. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies; 9. Other reasons for ineligibility as evaluated by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.