Health TrialsbyHealthPanel

An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age at time of informed consent

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1

Life expectancy of ≥6 months

Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors

Disqualifiers

For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously

Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer

Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.

Presence of active infections

Trial design

Design model

Single group

Treatments tested in this trial

  • ABO2109 Injection

    Drug

    personalized cancer vaccine

  • Toripalimab

    Drug

    Anti-PD-1 monoclonal antibody

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Dose Exploration PartExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration)

Time frame
From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
2

Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment (Dose Exploration)

Time frame
From the start of study intervention until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first
3

Changes in ECOG performance status score (Dose Exploration)

Time frame
From baseline until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first.
4

Disease-Free Survival (DFS) based on RECIST Version 1.1. (Dose Expansion)

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Suzhou Abogen Biosciences Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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