Personalized cancer vaccine added to adjuvant therapy for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early Phase 1/first-in-human study assesses safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and biomarker characteristics of ABO2109 when given with toripalimab in patients with solid tumors. The trial includes dose exploration and expansion cohorts to evaluate potential antitumor activity. Participants are adults with solid tumors who are perioperative/adjuvant or have advanced disease and meet specific health criteria. Data from this study will inform subsequent development of ABO2109 in combination with immune checkpoint inhibition. The study is led by Ruijin Hospital with collaboration from Abogen Life Sciences and related companies, and is conducted at Ruijin Hospital in Shanghai.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. ≥18 years of age at time of informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
3. Life expectancy of ≥6 months
4. Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors
5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention
6. Sufficient organ function
7. Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.

Key Exclusion Criteria:

1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
2. 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
3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
4. Presence of active infections
5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.

Where it's running

• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Baiyong Shen — Ruijin Hospital
• Study coordinator: Xinjing Wang
• Email: newvista89@163.com
• Phone: 18817821319

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.