OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07650825
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OVV-01 — DRUG
    OVV-01 is administered twice every two weeks
  • AK112 — DRUG
    AK112 is administered once every two weeks.

Study Details

This study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with advanced solid tumors.

Key Dates

First listed
Jun 16, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OVV-01 intravenous injection
    OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; Upon enrollment of 3 subjects in the OVV-01 monotherapy intravenous group with no DLT events, the combination therapy group may be initiated; In the combination therapy group, OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered.
  • Experimental: OVV-01 IV + IT
    OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; intratumoral injection and intravenous injection are completed on the same day. The OVV-01 monotherapy intravenous group may initiate the combination therapy group once 3 subjects are enrolled and no DLT events occur. For the combination therapy group: OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered. Intratumoral injection and intravenous injection are completed on the same day.

Primary Outcome Measure

DLT [ Time Frame: Within 21 days after administration ]

Central Contacts

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