NCT04721223

Brief Summary

To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2021

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

January 14, 2021

Last Update Submit

September 17, 2024

Conditions

Advanced Solid TumorEsophageal Squamous Cell CarcinomaNon Small Cell Lung CancerHead and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Number of participants with dose limiting toxicities

    Incidence of dose limiting toxicities (DLTs) . A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068 and JS001.

    24 months

  • Objective response rate (ORR)

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR).

    24 months

Secondary Outcomes (8)

  • Plasma concentration (Cmax)

    24 months

  • Time to achieve Cmax (Tmax)

    24 months

  • Area under the plasma concentration-time curve (AUC)

    24 months

  • Duration of response ( DCR )

    24 months

  • Progression-free survival (PFS)

    24 months

  • +3 more secondary outcomes

Study Arms (2)

JAB-3068+PD1 inhibitor Part1

EXPERIMENTAL

JAB-3068+JS001 dose escalation

Drug: JAB-3068Drug: PD1 inhibitor

JAB-3068+PD1 inhibitor Part2

EXPERIMENTAL

JAB-3068+JS001 dose expansion

Drug: JAB-3068Drug: PD1 inhibitor

Interventions

JAB-3068DRUG

JAB-3068 administrated orally as a tablet.

JAB-3068+PD1 inhibitor Part1JAB-3068+PD1 inhibitor Part2
PD1 inhibitorDRUG

JS001 administrated as an intravenous(IV) infusion.

JAB-3068+PD1 inhibitor Part1JAB-3068+PD1 inhibitor Part2

Eligibility Criteria

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

You may qualify if:

  • Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
  • Participant 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.

You may not qualify if:

  • History (≤3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer
  • Known serious allergy to experimental drugs
  • Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥21 days before the start of treatment with the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaCarcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of Head and Neck

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

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

January 14, 2021

First Posted

January 22, 2021

Study Start

April 26, 2021

Primary Completion

December 29, 2023

Study Completion

December 29, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)