A Trial of SHR-1701 in Subjects With Advanced Solid Tumors

Atridia

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SHR-1701

Study type: Interventional

Funder types: Industry

Identifiers

NCT04324814

SHR-1701-001AUS

Details and patient eligibility

About

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.

Full description

This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed (histologically or cytologically) with solid tumors
• ECOG Performance Status of 0 or 1 at both the screening and baseline visits
• Life expectancy ≥12 weeks
• Adequate laboratory parameters
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

Exclusion criteria

• Known history of hypersensitivity to the study drug
• Prior malignancy active within the previous 2 years
• Any investigational or concurrent cancer therapy
• History of immunodeficiency including seropositivity
• Systemic antibiotics treatment for ≥ 7 days before the first dose
• A known history of allogeneic organ transplantation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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41 participants in 7 patient groups

Dose level 1

Experimental group

Description:

Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle

Treatment:

Drug: SHR-1701

Dose level 2

Experimental group

Description:

Subjects will receive a single dose of SHR-1701 at Dose level 2 on Day 1 of each cycle

Treatment:

Drug: SHR-1701

Dose level 3

Experimental group

Description:

Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 of each cycle

Treatment:

Drug: SHR-1701

Dose level 4

Experimental group

Description:

Subjects will receive a single dose of SHR-1701 at Dose level 2 1 on Day 1 and Day 15 of each cycle

Treatment:

Drug: SHR-1701

Dose level 5

Experimental group

Description:

Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 and Day 15 of each cycle

Treatment:

Drug: SHR-1701

Dose expansion 1

Experimental group

Description:

Subjects will receive a single dose of SHR-1701 on a selected dose level Day 1 of each cycle

Treatment:

Drug: SHR-1701

Dose expansion 2

Experimental group

Description:

Subjects will receive a single dose of SHR-1701 on a selected dose level on Day 1 of each cycle

Treatment:

Drug: SHR-1701