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

Part of paid clinical trials in Lafayette, Indiana.

Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
Study ID
NCT04443088
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

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

Interventions

  • INV-1120 — DRUG
    INV-1120 is an investigational selective and potent small molecule indicated for the treatment of solid malignancies including, but not limited to colorectal, breast, pancreatic, lung and liver cancers.
  • Pembrolizumab — COMBINATION_PRODUCT
    Pembrolizumab will be administered as a dose of 200 mg on Day 1 of each 3-week treatment cycle.

Study Details

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.

Key Dates

Start date
Jun 26, 2020
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Dose Escalation
    Phase 1a: Subjects will receive escalating doses of INV-1120 orally once a day until un-acceptable toxicity or disease progression. Three to six patients will be enrolled per cohort to evaluate the safety and pharmacokinetics for each dose level. After the last patient in each cohort completes Cycle 1 (DLT observation period of 28 days), the Safety Evaluation Team (SET) will evaluate the safety data and pharmacokinetic collected from Cycle 1, and make the decision whether to escalate the dose before opening the second cohort. Phase 1b: Subjects will receive escalating and de-escalating doses of INV-1120 orally once a day in combination with pembrolizumab until un-acceptable toxicity or disease progression, and DLT observation period of 21 days.

Primary Outcome Measure

Phase 1a: Determine DLTs and RP2Ds in INV-1120 [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Horizon Oncology Research, LLC,LafayetteIndiana47905-
STARTSan AntonioTexas78229-
UT HealthSan AntonioTexas78229
Karla Hagerty
[email protected]
210-450-1920
John Sarantopoulos, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Horizon Oncology Research, LLC· Lafayette, INSTART· San Antonio, TXUT Health· San Antonio, TX

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