Actively Recruiting
A Phase 1a/1b, Open-Label Study of INV-1120 Alone and With Pembrolizumab in Adults With Advanced Solid Tumors
Led by Shenzhen Ionova Life Sciences Co., Ltd. · Updated on 2026-03-18
78
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating the safety, tolerability, and pharmacokinetics of INV-1120 alone and in combination with pembrolizumab in adult patients with advanced solid tumors. This phase 1, open-label, dose-escalation study aims to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dose-limiting toxicities (DLT) of INV-1120 as a single agent or combined with pembrolizumab. The trial includes patients whose tumors have progressed after standard therapies or have no standard treatment options. In Phase 1a, approximately 36 patients will receive escalating oral doses of INV-1120 once daily until unacceptable toxicity or disease progression occurs. Up to 9 additional patients may be enrolled to confirm safety at the MTD/RP2D. In Phase 1b, around 36-42 patients will receive escalating and de-escalating doses of oral INV-1120 combined with pembrolizumab, administered as 200 mg intravenously on Day 1 of each 3-week cycle, until toxicity or disease progression. Safety and tolerability of the combination will be confirmed in an expanded group of 12-15 patients. Participants will undergo safety evaluations during the first treatment cycle, including assessment of dose-limiting toxicities over 21 to 28 days depending on the phase. Researchers will monitor tumor response using imaging scans and assess pharmacokinetics through blood tests. Safety will be tracked using standard criteria for adverse events. The study period for primary outcome assessment is up to 12 months, during which patients will be closely observed for response, side effects, and drug levels to inform future dosing and treatment strategies.
CONDITIONS
Brief 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 informed consent before any study procedures
- Age 18 years or older at consent
- ECOG Performance Status of 0 or 1
- Advanced solid tumor confirmed by biopsy, 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 per RECIST v1.1
- Laboratory tests within acceptable limits for bone marrow, liver, and kidney function
- Negative pregnancy test for women of childbearing potential
- Use of two forms of contraception during and after study participation for patients of childbearing potential
- Ability to swallow and retain oral medication
You will not qualify if you...
- History or current cancer distinct from the study cancer within 5 years, except certain non-invasive cancers
- Serious allergy to study drug or excipients
- Severe autoimmune disease or immune-related adverse events requiring high-dose steroids
- Active malignant central nervous system disease except stable brain metastases
- Active infections Grade 2 or higher within 4 weeks
- HIV, hepatitis B or C positive status before treatment
- Severe or uncontrolled medical conditions affecting participation
- Recent serious heart conditions or impaired cardiac function
- QT interval prolongation beyond specified limits
- Pregnancy or breastfeeding
- Unwillingness or inability to use contraception as required
- Not recovered from prior treatment toxicities to baseline or Grade 1 (excluding minor toxicities)
- History of bone marrow or organ transplant
- Recent use of other systemic anti-cancer agents or investigational drugs
- Recent radiation therapy or planned radiation within 30 days post-treatment
- Recent major surgery or ongoing post-operative complications
- Recent platelet transfusion or growth factor use
- Use of medications with risk of Torsades de Pointes without appropriate washout
- Recent use of H2 blockers or proton pump inhibitors
- Recent or current gastroesophageal ulcer
- For Phase 1b: prior severe immune-related adverse events from immune checkpoint inhibitors
- Participation in other investigational studies within 30 days
- Recent live vaccine administration
- Severe hypersensitivity to pembrolizumab
- History or current pneumonitis or interstitial lung disease requiring steroids or radiation pneumonitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until unacceptable toxicity or disease progression
Participants receive escalating doses of INV-1120 orally once a day in Phase 1a until unacceptable toxicity or disease progression. In Phase 1b, participants receive escalating and de-escalating doses of INV-1120 orally once a day in combination with pembrolizumab administered at 200 mg on Day 1 of each 3-week cycle until unacceptable toxicity or disease progression.
Multiple visits corresponding to treatment cycles every 3 weeks
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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