Actively Recruiting
An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
Led by Shenzhen Ionova Life Sciences Co., Ltd. · Updated on 2026-03-18
78
Participants Needed
3
Research Sites
339 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Ionova Life Sciences Co., Ltd.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.
CONDITIONS
Official Title
An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- 18 years of age or older at consent
- ECOG Performance Status score of 0 or 1
- Histologically or cytologically confirmed advanced solid tumors progressed after standard therapy or no standard therapy available
- Life expectancy of at least 3 months
- At least one measurable lesion by CT or MRI according to RECIST v1.1
- Acceptable bone marrow, liver, and renal function laboratory results at screening
- Negative urine pregnancy test for women of childbearing potential
- Use of two forms of contraception including one barrier method by males with female partners of childbearing potential and female participants of childbearing potential during study and 3 months after last dose
- Ability to swallow and retain oral medication
You will not qualify if you...
- History or current evidence of cancer distinct from the cancer under study within 5 years, except certain specified cancers
- Serious allergy to investigational drugs or excipients
- Severe autoimmune disease or autoimmune disorder requiring immunosuppressive corticosteroids
- Malignant central nervous system disease except stable treated brain metastases
- Active infections of Grade 2 or higher within 4 weeks of treatment
- Seropositive for HIV, hepatitis B, or hepatitis C before treatment
- Severe or uncontrolled medical conditions affecting participation
- Cardiovascular events within 6 months before treatment
- Impaired cardiac function or significant cardiac diseases
- QT interval prolongation exceeding specified thresholds
- Pregnant or breastfeeding women
- Unwillingness or inability to use acceptable contraception
- Not recovered from prior anticancer therapy toxicity to baseline or Grade 1
- History of allogeneic bone marrow or solid organ transplant
- Recent use of systemic anticancer agents or investigational drugs within 28 days
- Recent radiation therapy within 28 days or planned within 30 days after last dose except limited palliative radiation
- Major surgery within 4 weeks before enrollment or ongoing postoperative complications
- Recent platelet transfusion within 2 weeks before treatment
- Recent use of certain blood growth factors within 3 weeks before screening
- Use of medications with risk of Torsades de Pointes without proper washout
- Recent use of H2 blockers or proton pump inhibitors before and during study
- Recent or current gastroesophageal ulcer within past 12 months
- Additional Phase 1b exclusions including prior severe immune-related adverse events from similar agents, participation in other investigational studies within 30 days, recent live vaccines, severe hypersensitivity to pembrolizumab, and history or current pneumonitis or interstitial lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Horizon Oncology Research, LLC,
Lafayette, Indiana, United States, 47905
Completed
2
START
San Antonio, Texas, United States, 78229
Completed
3
UT Health
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
R
radhika Shah, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here