A Study of RC98 in Subjects With Advanced Malignant Solid Tumors

NCT04190823 | Unknown Phase 1

• 1 other identifier: RC98-C001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability and pharmacokinetics of RC98 for injeciton in subjects with advanced malignant solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03

  From the day of ICF sign to 28 days after the day of the last treatment

• Maximum Tolerated dose of RC98

  The dose level in which \>= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.

  12 months

Secondary Outcomes (2)

• Objective Response Rate(ORR)

  15 months

• Progression Free Survival (PFS)

  15 months

Study Arms (1)

RC98

EXPERIMENTAL

Drug: RC98

Interventions

RC98 DRUG

Participants will be allocated to one of the following dose groups: 0.003, 0.03, 0.3, 2.5, 5.0, 10.0, 15.0 and 20.0 mg/kg, and receive one treatment of RC98 followed by 28 days of dose limited toxicity (DLT) observation period.

Also known as: RC98 for Injection

RC98

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary agreement to provide written informed consent.
• Male or female, Age ≥ 18 years.
• Predicted survival ≥ 12 weeks.
• Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic solid tumors.
• Measurable lesion according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment:
• Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 90g/L; Absolute neutrophil count ≥ 1.5×10\^9 /L Platelets ≥ 100×10\^9 /L; Total bilirubin ≤ 1.5× ULN and ≤ 1.5× ULN with hepatic metastasis; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN; INR, APTT and PT ≤ 1.5× ULN; TSH or FT4 or FT3 in (1±10%) ULN.
• 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.
• Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

You may not qualify if:

• Known hypersensitivity to the components of RC98 for injection.
• Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
• Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
• History of receiving any research drug treatment within 4 weeks prior to trial treatment.
• History of major surgery, chemotherapy or radiotherapy within 4 weeks of planned start of trial treatment.
• History of arterial / venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before study medication.
• NYHA Class III heart failure.
• Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
• Currently known active infection with HIV or tuberculosis.
• Diagnosed with HBsAg , HBcAb positive and HBV DNA copy positive, or HCVAb positive.
• Uncontrolled hypertension, diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or cirrhosis;
• Treated with corticosteroids or other immunosuppressants for the autoimmune disease within 14 days prior to the study treatment.
• Existing active, or have experienced autoimmune diseases that may recur (eg: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis Disease, etc.) or subjects with these disease risks.
• Pregnancy or lactation.
• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 9, 2019
• Study Start: March 15, 2020
• Primary Completion: December 28, 2023
• Study Completion: December 30, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)