A Study of RC108-ADC in Subjects With Advanced Malignant Solid Tumors

RemeGen

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: RC108

Study type: Interventional

Funder types: Industry

Identifiers

NCT04617314

RC108-C001

Details and patient eligibility

About

This study will evaluate the safety, pharmacokinetics, and effect of RC108-ADC for injeciton in subjects with c-Met positive advanced malignant solid tumors.

Enrollment: 67 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary agreement to provide written informed consent.
2. Male or female, aged between 18 to 70 years.
3. Predicted survival for ≥ 12 weeks.
4. Diagnosed with histologically or cytologically confirmed locally advanced or metastatic solid tumors.
5. Measurable lesion according to RECIST 1.1.
6. c-Met positive as confirmed by the central laboratory. The subject is able to provide specimens from primary or metastatic lesions for c-Met tests.
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
8. Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment:
9. Cardiac ejection fraction ≥ 50%. Median QTc < 450 ms. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9 /L Platelets ≥ 100×10^9 /L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN.
10. All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
11. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion criteria

1. Known hypersensitivity to the components of RC108-ADC.
2. Toxicity of previous anti-tumor treatment not recovered to CTCAE (v5.0) Grade 0-1 (with exception of Grade 2 alopecia).
3. Uncontrolled pericardial effusion or cardiac tamponade, or pleural or abdominal effusion with clinical symptoms.
4. History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
5. History of major surgery within 4 weeks of planned start of trial treatment.
6. Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
7. Currently known active infection with HIV or tuberculosis.
8. Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
10. History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
11. Known central nervous system metastases.
12. Uncontrolled hypertension, diabetes, pulmonary fibrosis, acute lung disease, Interstitial lung disease, or liver cirrhosis;
13. Pregnancy or lactation.
14. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

RC108

Experimental group

Description:

Participants will be allocated to one of the following dose groups: 0.1, 0.3, 0.9, 1.5, 2.0, 2.5, and 3.0mg/kg, and receive a treatment of RC108-ADC followed by 21 days of dose limited toxicity (DLT) observation period.

Treatment:

Drug: RC108