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Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors

ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Abogen Biosciences Co., Ltd.

About this trial

This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must be ≥18 years olde.

Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.

Histopathology or cytology confirmed Advanced solid tumors;

Failed of previous systemic treatment or required treatment histories for selected tumor types;

Disqualifiers

Other malignancies within the previous 5 years, with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of breast, and carcinoma in situ of the cervix.

Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control.

History of serious cardiac disease, e.g., New York Heart Association (NYHA) ≥ Grade 2 cardiac failure, history of transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, myocardial infarction within 6 months prior to enrollment, or arrhythmias requiring antiarrhythmic therapy (β-blockers, calcium channel blockers, and digoxin are allowed). QTcF > 480 ms.

Poorly controlled clinical complications, including, but not limited to, uncontrolled hypertension with both antihypertensive agents Hypertension and hypoglycemic treatment not Controlled type 2 diabetes, poorly controlled pleural, ascites, or other serious diseases requiring systemic treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • ABO2011 Injection

    Drug

    Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection

  • Toripalimab

    Drug

    Anti-PD-1 antibody

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: ABO2011Experimental treatment 1 intervention
Group B: ABO2011 and ToripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase I: Incidence and character of DLTs

Time frame
monotherapy: 21 days after the first dose. Combination therapy: 28 days after the first dose]
2

Phase I: Incidence of Adverse Event (AE)

Time frame
monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.
3

Phase I: Incidence of Serious Adverse Event (SAE)

Time frame
monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.]
4

Phase I: Incidence of patients with clinically significant abnormal laboratory results

Time frame
monotherapy: from the first dose until 28 days of last administration. Combination therapy: from informed consent until 90 days after the last administration.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Abogen Biosciences Co., Ltd.

Lead sponsor

Abogen Life Sciences (Shanghai) Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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