NCT06730386 A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors
| NCT ID | NCT06730386 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Akeso |
| Condition | Solid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2028-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-02-24 with a primary completion date of 2028-02-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment; 6. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement. 7. 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. 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; 5. 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; 6. 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; 7. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease; 8. Active syphilis infection; 9. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies; 10. Other reasons for ineligibility as evaluated by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06730386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06730386 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06730386 currently recruiting?
Yes, NCT06730386 is actively recruiting participants. Contact the research team at wenting01.li@akesobio.com for enrollment information.
Where is the NCT06730386 trial being conducted?
This trial is being conducted at Blacktown, Australia, North Ryde, Australia, South Brisbane, Australia, Frankston, Australia.
Who is sponsoring the NCT06730386 clinical trial?
NCT06730386 is sponsored by Akeso. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.