About this trial

This is a Phase 1, open-label, dose-escalation and cohort expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant protein) combine with IMM01(Anti-CD47 Recombinant Protein) in patients with advanced solid tumors who have received at least first line treatment in past.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has provided informed consent prior to initiation of any study specific activities/procedures.

Age greater than or equal to 18 years old at the same time of signing the informed consent.

Histologically or cytologically confirmed for Solid Tumor.

Eastern Cooperative Oncology Group (ECOG) 0 to 1.

Disqualifiers

History of other malignancy within the past 5 years with exceptions.

Systemic chemotherapy was administered within 3 weeks prior to the first administration.

Activated symptomatic brain metastases and leptomeningeal disease.

History of inflammatory bowel disease.

Trial design

Design model

Sequential

Treatments tested in this trial

IMM2510
Biological/Vaccine
IMM2510 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM2510 (e.g., 10 mg/kg, 20 mg/kg, up to maximum tolerated dose or recommended phase 2 dose).
IMM01
Biological/Vaccine
IMM01 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM01 (e.g., 1 mg/kg, 2 mg/kg, 3mg/kg, up to maximum tolerated dose or recommended phase 2 dose).

Treatment groups

104 Participants

are divided into 1 treatment group

Group A: Cohort 1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

DLT/MTD (Dose Escalation Phase)

Time frame

Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1)

2

Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)

Time frame

From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment

3

Objective Response Rate (ORR)

Time frame

From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.

4

RP2D (Dose Extension Phase)

Time frame

From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 96 weeks

Secondary outcomes

1

Disease Control Rate(DCR)

Time frame

From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.

2

Duration of Response (DOR)

Time frame

From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.

3

progression- free survival(PFS)

Time frame

From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.

4

overall survival（OS）

Time frame

From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.

A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts