First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EpimAb Biotherapeutics (Suzhou)Co., Ltd.

Criteria

Inclusion Criteria:

1. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.

2. Male or female, and aged ≥ 18 years

3. Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative breast cancer, lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric cancer, prostate cancer, bladder cancer, and uterus cancer

4. Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or evaluable disease per RECIST V1.1.

5. Patients must provide archival tumor samples, or a biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken ≤ 2 years prior to screening, otherwise a fresh tumor biopsy at screening is required.

6. ECOG performance status 0 or 1

7. Adequate organ function to participate in the trial.

8. Recovery from adverse events (AEs) related to prior anticancer therapy.

Exclusion Criteria:

1. Prior treatment with any agent targeting ROR1.

2. History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.

3. Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of investigator or if radiation therapy for CNS metastases is completed > 4 weeks prior to study treatment.

4. Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment.

5. Abuse on alcohol, cannabis-derived products, or other drugs.