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INV-1120 + Pembrolizumab for Advanced Cancer

Q: What are the major goals of this medical research?

<p>According to the information provided by Merck Sharp &#x26; Dohme LLC, this trial's primary objective is Phase 1a: Establish DLTs and RP2Ds in INV-1120 over a 12 month time frame. Additionally, there are three secondary goals which will be monitored - AE, clinical lab test results, ECG and Vital signs changes; AUC of INV-1120 after single doses and at steady state after multiple doses; Cmax of INV-1120 following single dose and at equilibrium post serial administration.</p>

Phase 1

Recruiting

Research Sponsored by Shenzhen Ionova Life Sciences Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will assess the safety and tolerability of the investigational drug INV-1120, either as a single agent or in combination with pembrolizumab, in adult patients with advanced solid tumors.

Who is the study for?

Adults with advanced solid tumors who've tried standard treatments or have none available. They must be over 18, able to swallow pills, not pregnant, and agree to use two forms of contraception. Excluded are those with certain infections, brain metastases, recent major surgery or heart issues, and severe allergies.Check my eligibility

What is being tested?

The trial is testing INV-1120 alone and combined with Pembrolizumab in adults with advanced solid tumors. It's an early-phase study to find the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, and how the body processes these drugs.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site where the drug enters the body through a vein; immune system-related issues affecting organs; fatigue; digestive problems like nausea or diarrhea; skin reactions; hormonal changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

Phase 1a: Characterize the safety of INV-1120 as assessed by CTCAE v5.0

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

+4 more

Other outcome measures

Phase 1a: Characterize investigator defined DOR using iRECIST

Phase 1a: Characterize investigator defined ORR using iRECIST

Phase 1a: Characterize investigator defined PFS using iRECIST

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Shenzhen Ionova Life Sciences Co., Ltd.Lead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,979 Total Patients Enrolled

Media Library

INV-1120 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04443088 — Phase 1

Cancer Research Study Groups: Dose Escalation

Cancer Clinical Trial 2023: INV-1120 Highlights & Side Effects. Trial Name: NCT04443088 — Phase 1

INV-1120 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04443088 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are currently participating in this research project?

"Affirmative. Clinicaltrials.gov data reveals that, since its initial posting on June 26th 2020, this investigation is actively looking for participants. 78 people between two medical centres must be recruited to participate in the study."

Answered by AI

What potential risks are associated with this remedial approach?

"In accordance with our team at Power's evaluation, this treatment is given a safety rating of 1 because it is only in Phase 1 trials and there are limited data points supporting its efficacy."

Answered by AI

Is this trial currently accepting participants?

"According to the clinicaltrials.gov website, this investigation is actively seeking participants and has been since June 26th 2020; its details were most recently modified on August 18th 2022."

Answered by AI

What are the major goals of this medical research?

"According to the information provided by Merck Sharp & Dohme LLC, this trial's primary objective is Phase 1a: Establish DLTs and RP2Ds in INV-1120 over a 12 month time frame. Additionally, there are three secondary goals which will be monitored - AE, clinical lab test results, ECG and Vital signs changes; AUC of INV-1120 after single doses and at steady state after multiple doses; Cmax of INV-1120 following single dose and at equilibrium post serial administration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04443088.