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

NCT04443088 | Recruiting Phase 1 FDA Drug

• 1 other identifier: INV-1120-101(MK-3475-E12)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

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

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

Keywords

Ionova; Ionova Bio; Cancer; Oncology

Outcome Measures

Primary Outcomes (2)

• Phase 1a: Determine DLTs and RP2Ds in INV-1120

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

  12 months

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

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

  12 months

Secondary Outcomes (7)

• Phase 1a: Determine the PK using AUC of INV-1120

  12 months

• Phase 1b: Determine the PK using AUC of INV-1120

  12 months

• Phase 1a: Determine the PK using Cmax of INV-1120

  12 months

• Phase 1b: Determine the PK using Cmax of INV-1120

  12 months

• Characterize investigator defined response overall response rate (ORR) etc using RECIST v1.1

  12 months

Other Outcomes (3)

• Phase 1a: Characterize investigator defined ORR using iRECIST

  12 months

• Phase 1a: Characterize investigator defined PFS using iRECIST

  12 months

• Phase 1a: Characterize investigator defined DOR using iRECIST

  12 months

Study Arms (1)

Dose Escalation

OTHER

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.

Drug: INV-1120; Combination Product: Pembrolizumab

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.

Dose Escalation

Pembrolizumab COMBINATION_PRODUCT

Pembrolizumab will be administered as a dose of 200 mg on Day 1 of each 3-week treatment cycle.

Also known as: KEYTRUDA®

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses;
• Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF);
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
• Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no standard therapy exists;
• Patients with life expectancy ≥3 months;
• Patients with at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), according to RECIST v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated;
• Patients whose laboratory data at screening meet the acceptable criteria for bone marrow, liver function and renal function.
• Women of childbearing potential (WOCBP) must have a negative urine pregnancy test during screening. A woman is considered of childbearing potential (fertile) following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Postmenopausal women can be included;
• Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 3 months following last dose. Medically acceptable contraception includes:
• 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
• 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;
• Patients must be able to swallow and retain orally administered medication.

You may not qualify if:

• History (≤5 years) or current evidence of cancer that is histologically distinct from the cancer under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer. Patients with hepatocellular carcinoma will be excluded from Phase 1b dose escalation;
• Known serious allergy to investigational drug or excipients (microcrystalline cellulose);
• History of severe autoimmune disease (including significant ongoing immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent);
• Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastases having been treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage and off any systemic corticosteroids for at least 4 weeks prior to signing the consent;
• History (within 4 weeks of starting treatment) or evidence of active infections (Grade ≥2);
• Seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at any time before the start of treatment: Testing for seropositive status during screening will be at the discretion of the Investigator in patients without previously reported results;
• History or evidence of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study, such as any disorder or surgical procedure that could impact the absorption of study drug from the gastrointestinal tract.
• History (≤6 months before the start of treatment) or evidence of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, cerebrovascular accident, or transient ischemic attack;
• Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• 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;
• 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);
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Shenzhen Ionova Life Sciences Co., Ltd.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Horizon Oncology Research, LLC,

Lafayette, Indiana, 47905, United States

COMPLETED

START

San Antonio, Texas, 78229, United States

COMPLETED

UT Health

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

radhika Shah, MD

CONTACT

1 984 459 5523; radhika.shah@syneoshealth.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 23, 2020
• Study Start: June 26, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)