NCT05438420

Brief Summary

This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
23mo left

Started Jan 2023

Longer than P75 for phase_1

Geographic Reach
2 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2023Mar 2028

First Submitted

Initial submission to the registry

May 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 12, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

May 20, 2022

Last Update Submit

February 23, 2026

Conditions

Esophageal CancerGastric CancerHepatocellular CancerCervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of participants with treatment-related adverse events as assessed by CTCAE

    Up to approximately 2 years (Each Cycle is 42 Days)

  • Tumor response using RECIST version 1.1 throughout study

    Up to approximately 2 years (Each Cycle is 42 Days)

Secondary Outcomes (1)

  • Change in the area under curve (AUC) of Q702 and its primary metabolites

    Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)

Study Arms (2)

Dose escalation of Q702 in combination with fixed dose of pembrolizumab

EXPERIMENTAL

Give one week on/one week off at selected dose level

Drug: Q702Biological: Pembrolizumab

Dose expansion of Q702 in combination with fixed dose of pembrolizumab

EXPERIMENTAL

Give intravenously once every three week at 200 mg

Drug: Q702Biological: Pembrolizumab

Interventions

Q702DRUG

The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle.

Dose escalation of Q702 in combination with fixed dose of pembrolizumabDose expansion of Q702 in combination with fixed dose of pembrolizumab
PembrolizumabBIOLOGICAL

Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle

Also known as: KEYTRUDA®
Dose escalation of Q702 in combination with fixed dose of pembrolizumabDose expansion of Q702 in combination with fixed dose of pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
  • Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy of at least 3 months

You may not qualify if:

  • A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women
  • Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
  • Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
  • Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
  • Has had an allogeneic tissue/solid organ transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Southern California

Los Angeles, California, 90033, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

CHA Bundang Medical Center

Seongnam-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsLiver NeoplasmsUterine Cervical Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesLiver DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 30, 2022

Study Start

January 12, 2023

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

US(2)KR(5)