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Study of INV-1120 for Advanced Solid Tumors

This study is testing a new drug called INV-1120, both on its own and in combination with an existing cancer drug called pembrolizumab. It's for adults with advanced solid tumors, which are cancers that have grown or spread. The main goals are to find the safest and most effective dose of INV-1120, alone and with pembrolizumab, and to see how well patients tolerate the treatments. You might be able to join if you are at least 18 years old, have advanced solid tumors, and meet certain health criteria. The study is currently recruiting about 78 patients.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve about 78 adult patients with advanced solid tumors.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main safety and dosing information will be collected over 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04443088

An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Shenzhen Ionova Life Sciences Co., Ltd.
~78 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:INV-1120Pembrolizumab

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Determine DLTs and RP2Ds in INV-1120
Measured over 12 months
+1 more outcome measured

Conditions

Cancer
Solid Tumor, Adult
Cancer Metastatic
Solid Carcinoma
Solid Tumor, Unspecified, Adult
Tumor, Solid

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Solid Neoplasm

NCT04443088

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UT Health

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Horizon Oncology Research, LLC,

    Lafayette, Indianano site contact published

    Completed

  • START

    San Antonio, Texasno site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

radhika Shah, MD
[email protected]
1 984 459 5523
Email the study team

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Eligibility criteria

Inclusion

Hormonal methods (Needs to have been instituted at least 1 month prior to the first dose of study drug):
Barrier methods:
Abstinence, defined as refraining from sexual intercourse 10. Male patients must also refrain from donating sperm from the first dose of study drug until 4 months after the last dose of study drug; 11. Patients must be able to swallow and retain orally administered medication.

Exclusion

Congenital long QT syndrome;
Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible);
LVEF \< 50% by ECHO or MUGA;
Other clinically significant heart disease such as known congestive heart failure New York Heart Association (NYHA) Class III-IV; 10. Patients with QT interval ≥470 msec in females and ≥450 msec in males at screening using Fridericia's formula (determined as the mean of 3 QTcF values from the screening triplicate ECG obtained with adequate quality); 11. Women who are pregnant or breastfeeding. 12. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy for at least 1 month before the first dose of the study drug, during the study, and for 4 months after the last dose of study drug; 13. Male patient who plans to father a child while enrolled in this study or within 4 months after the last dose of study drug; 14. Not recovered from toxicity from prior anticancer therapy to baseline or Grade 1 (except toxicities which are not clinically significant such as alopecia, skin discoloration). 15. History of an allogeneic bone marrow or solid organ transplant; 16. Use of systemic anti-cancer agent (except luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab) or investigational drug ≤28 days or five half-lives whichever is shorter prior to the first dose of study treatment; 17. Radiation therapy ≤28 days prior to the first dose of study treatment, or likely to require radiation therapy at any time until the 30 days after the last dose of study treatment, except for palliative radiation therapy limited to non-target bone lesions; 18. Major surgery within 4 weeks before enrollment or surgery with ongoing post-operative complications); 19. History of transfusion of platelets ≤2 weeks before the start of treatment; 20. Patients who start erythropoietin or granulocyte-colony stimulating factor (G-CSF), pegfilgrastim, or filgrastim ≤3 weeks before screening; 21. Patients taking medications known to have a significant risk of causing Torsades de Pointes. Patients who have discontinued any of these medications must have a wash-out period of at least 7 days or at least 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug. 22. History of use of H2 blockers (\<24 hours before the first dose of study treatment and during the study) and proton pump inhibitors (\<5 days before the first dose of study treatment and during the study). 23. Patients with recent (within past 12 months) history, or are currently being treated for gastroesophageal ulcer.

What this trial measures

  • Phase 1a: Determine DLTs and RP2Ds in INV-112012 months

    To evaluate dose limiting toxicities (DLTs) of INV-1120 in patients with advanced cancer and to establish a recommended Phase 2 dose (RP2D)

  • Phase 1b: Determine RP2D and DLTs of the combination of INV-1120 and pembrolizumab12 months

    To determine RP2D, and to assess DLT of the combination of INV-1120 and pembrolizumab administered to adult patients with advanced solid tumors.