Study of SHR2150 (TLR7 Agonist) in Combination With Chemotherapy Plus PD-1 or CD47 Antibody in Subjects With Unresectable/ Metastatic Solid Tumors

NCT04588324 | Unknown Phase 1 DMC

• 1 other identifier: CHN-PLAGH-BT-059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II trial aims to evaluate safety and efficacy of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody in subjects with unresectable/ metastatic solid tumors. Patients will receive the combined regimen in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, three oral doses of SHR2150 will be combined with intravenous administration of chemotherapy and PD-1 or CD47 antibody. In the Phase 2 dose expansion portion, patients will be treated with the Recommended Phase 2 Dose (RP2D) of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody.

Conditions

Solid Tumor

Keywords

unresectable; metastatic; TLR7 agonist; anti-PD-1 antibody; anti-CD47 antibody; chemotherapy

Outcome Measures

Primary Outcomes (3)

• Safety of the combined regimen of SHR2150, chemotherapy, PD-1 or CD47 antibody

  Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.

  60 days after last dose

• Identify a RP2D of SHR2150 when given in combined regimen

  The Recommended Phase 2 Dose (RP2D) of SHR2150 in the combined regimen will be identified at Phase 1 dose escalation period, and will be used in the phase 2 dose expansion period.

  30 days

• Object response rate (ORR)

  ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  24 month

Secondary Outcomes (5)

• Disease control rate (DCR)

  24 months

• Progression-free survival (PFS)

  24 months

• Duration of Response (DOR)

  24 months

• Overall survival (OS)

  24 months

• Time to Response (TTR)

  6 months

Other Outcomes (2)

• Number of participants with laboratory test abnormalities

  Approximately 6 months

• Number of participants with pathological immunology marker change

  Approximately 6 months

Study Arms (2)

Phase 1 Dose-Escalation

EXPERIMENTAL

With a standard 3+3 dose escalation design, the enrollment will proceed until the MTD has been defined or the highest dose level has been reached.

Drug: SHR2150; Drug: Anti-Cancer Agent

Phase 2 Dose-Expansion

EXPERIMENTAL

SHR2150 RP2D will be combined with chemotherapy plus PD-1 or CD47 antibody in 3-week treatment cycles.

Drug: Anti-Cancer Agent; Drug: SHR2150

Interventions

SHR2150 DRUG

Patients will receive escalating doses of SHR-2150 (starting dose 2 mg) in 3-week treatment cycles.

Phase 1 Dose-Escalation

Anti-Cancer Agent DRUG

The previously resistant first-line cytotoxic regimens, anti-PD-1 antibody and/or anti-CD47 antibody will be administered intravenously Q3W.

Phase 1 Dose-Escalation; Phase 2 Dose-Expansion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically proven unresectable/ metastatic solid tumors.
• ≥ 18 years old.
• Life expectancy of at least 6 months.
• Eastern Cooperative Oncology Group performance status 0-3.
• Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
• Subjects must have received at least two frontlines therapies, except for patients initially diagnosed with local advanced or metastatic pancreatic cancer or cholangiocarcinoma.
• Subjects must be off prior therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Subjects with Anti-PD-1 antibody are eligible which must be resistance.
• Adequate organ function.
• Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
• Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.

You may not qualify if:

• Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
• Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
• Prior organ allograft.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or prior to investigational product administration.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Weidong Han

  Biotherapeutic Department of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Han, M.D.

CONTACT

+861066937463; hanwdrsw@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 19, 2020
• Study Start: October 10, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

CN (1)