About this trial

The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) . This clinical trial will include solid tumor patients who failed standard treatment.

The main questions to answer are:

Safety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recurrent or metastatic solid tumors that have been histologically or cytologically pathologically confirmed and are not amenable to radical treatment with surgery or local therapy.

Patients with advanced or recurrent solid tumors who have failed prior standard therapy.

Expected survival period >6 weeks at the time of informed consent.

Adequate organ function

Disqualifiers

Primary central nervous system (CNS) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with CNS metastases.

Uncontrolled co-morbidities.

Cerebrovascular event (stroke, transient ischemic attack, etc.) within 4 months prior to the signing of inform consent form.

In screening period male QTcF interval >450 ms; Female QTcF interval >470 ms (calculated by the Fridericia formula).

Trial design

Design model

Sequential

Treatments tested in this trial

EVM16
Biological/Vaccine
cancer vaccine
Tislelizumab
Drug
Anti-PD1 antibody

Treatment groups

78 Participants

are divided into 4 treatment groups

Group A: Dose Escalation Level 1Experimental treatment 2 interventions

Group B: Dose Escalation Level 2Experimental treatment 2 interventions

Group C: Dose Escalation Level 3Experimental treatment 2 interventions

Group D: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

safety and tolerability

The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), the incidence of dose-limiting toxicity (DLT) （only in phase Ia）, and the incidence of AEs of grade 3 or higher were assessed according to the NCI CTCAE v5.0 in the treatment of EVM16 alone as well as EVM16 in combination with Tislelizumab.

Time frame

From the first study intervention to 90 days after the last study intervention.

2

RP2D for EVM16

Based on safety, tolerability, immunogenicity to determine RP2D.

Time frame

During the intervention, up to approximately 1 year.

Secondary outcomes

1

immunogenicity of EVM16

Based on proportion of IFN-γ-positive T cells and/or T cell receptor sequences after EVM16 administration to assess the immunogenicity of EVM16 in subjects with advanced or recurrent solid tumours.

Time frame

during the intervention, up to 1 year

2

objective response rate (ORR) of EVM16 in combination with tislelizumab

Proportion of patients with partial response (PR) and complete response (CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.

Time frame

From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.

3

disease control rate (DCR) of EVM16 in combination with tislelizumab

Proportion of patients with partial response (PR) , complete response (CR) and stable disease (SD) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.

Time frame

From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.

4

duration of disease remission (DOR) of EVM16 in combination with tislelizumab

Duration of objective response (PR and CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.

Time frame

From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.

EVM16 Injection as a Single and Combination With Tislelizumab in 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