CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma

NCT05257590 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CVM-008
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 5

Brief Summary

CVM-1118 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human has been evaluated from the phase 1 study. The objective of the phase 2 study is to further investigate the efficacy of CVM-1118 with nivolumab for subjects with unresectable advanced hepatoma.

Conditions

Hepatocellular Carcinoma; Advanced Cancer

Keywords

Oncology; Hepatocellular Carcinoma (HCC); Nivolumab; Hepatoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)_mRECIST

  Assessment by modified RECIST criteria

  24 weeks after the last subject starts CVM-1118

Secondary Outcomes (21)

• Objective Response Rate (ORR)_RECIST v1.1

  24 weeks after the last subject starts CVM-1118

• Duration of response (DoR)

  24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose

• Progression free survival (PFS)

  24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose

• Overall survival (OS)

  24 weeks after the last subject starts CVM-1118 and up to 1 year after the last-dose

• Time to progression (TTP)

  24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose

Study Arms (1)

Nivolumab + CVM-1118

EXPERIMENTAL

1 Cycle = 28 days Nivolumab, 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting from Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability. CVM-1118, 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects. Escalation of the starting dose will be dependent on the absence of Dose Limiting Toxicity in at least 7 of the initial 10 subjects treated at 200 mg, PO, BID. Individual subjects receiving a starting dose of 200 mg, PO, BID and who tolerate the initial 2 cycles with no more than Grade 2 related toxicity, will have the option of increasing their dose of CVM-1118 to 300 mg, PO, BID (600 mg total daily dose) starting with cycle 3 Tolerable dose of Nivolumab and CVM-1118 will be administered continuously for a 28-day cycle until progressive disease, unacceptable toxicity, or consent withdrawal.

Drug: Nivolumab Injection [Opdivo]; Drug: CVM-1118

Interventions

Nivolumab Injection [Opdivo] DRUG

Nivolumab will be administered at 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting with Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability.

Also known as: Nivolumab

Nivolumab + CVM-1118

CVM-1118 DRUG

CVM-1118 will be administered 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects.

Also known as: TRX-818

Nivolumab + CVM-1118

Eligibility Criteria

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

You may qualify if:

• Age 18+ (20+ for subjects in Taiwan)
• Diagnosis of hepatocellular carcinoma
• Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)
• Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).
• Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C
• Child-Pugh liver function class A
• Measurable disease (per mRECIST)
• ECOG performance status of 0 to 1
• Adequate laboratory parameters including:
• AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement)
• Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome)
• ANC ≥1500/µL
• Platelets ≥ 90,000/µL
• HGB ≥ 9.0 g/dL
• Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula

You may not qualify if:

• HCC with portal vein invasion at the main portal branch (Vp4)
• Known history of esophageal varices or gastrointestinal bleeding within the past 3 months
• Prior immunotherapy for hepatoma
• ≤ 7 days from prior limited field palliative irradiation therapy and C1D1
• ≤ 28 days from prior irradiation therapy and C1D1
• ≤ 14 days (or 5 half-lives) from prior systemic anticancer therapy and C1D1
• ≤ 28 days from local regional therapy (e.g., trans-arterial embolization, radiofrequency ablation) and C1D1
• Presence of other active cancer(s) likely to require treatment in the next two (2) years or likely to impact the assessment of any study endpoints
• Active bacterial or fungal infection(s) requiring systemic therapy within 7 days prior to C1D1
• Known CNS metastases
• Known history of HIV infection
• Females who are currently pregnant or breast-feeding
• Known gastrointestinal disease that may significantly alter the absorption of oral medications
• Psychiatric illness or social situation that would interfere with compliance with study requirements
• History of clinically significant cardiovascular abnormalities

Sponsors & Collaborators

• TaiRx, Inc.: lead

Study Sites (5)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pei-Jer Chen, MD/PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Ling Chen, PhD

CONTACT

886-2-2653-5007; yenlingchen@trx.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 25, 2022
• Study Start: May 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

TW (5)