Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System

NCT06824792 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: SINGULARITY-001
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well as its superiority compared to clinician-selected treatment plans. A multi-agent system based on multimodal AI models will rank the priority of standard treatment options based on the personalized information of the patients, including including demographics, clinical information, and multi-omics data. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.

Conditions

Advanced Solid Tumors

Keywords

Artificial Intelligence; Real World Study; Advanced Solid Tumors; Standard Treatment; Multi-omics

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Defined as the time from enrollment to documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

  Every 6 weeks, up to 2 years since enrollment

Secondary Outcomes (6)

• Overall response rate (ORR)

  Every 6 weeks, up to 2 years since enrollment

• Duration of response (DoR)

  Every 6 weeks, up to 2 years since enrollment

• Time to treatment failure (TTF)

  Every 6 weeks, up to 2 years since enrollment

• Time to progression (TTP)

  Every 6 weeks, up to 2 years since enrollment

• Best of response (BoR)

  Every 6 weeks, up to 2 years since enrollment

Study Arms (1)

Quasar

EXPERIMENTAL

This arm involves the prospective collection of individual patient data, including demographic information, clinical details (such as pathological classification, tumor staging, imaging findings, prior treatments and their efficacy, and performance status scores), and multi-omics data (DNA gene panel testing, whole-exome sequencing, and transcriptome sequencing). An artificial intelligence model (namely, Quasar) integrates this multidimensional information to prioritize standard treatment options and identify the optimal personalized treatment plan for each patient. Based on the AI-recommended treatment list, the final treatment plan is jointly selected by the patient and the physician. If treatment adjustments are required due to tumor progression, intolerance, or other reasons, the AI model will generate a new optimal treatment plan based on updated patient characteristics. This iterative process continues until the patient withdraws from the study.

Drug: Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE.

Interventions

Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE. DRUG

Quasar is a biologically-informed multi-agent system developed based on multi-omics and multi-modal data. By integrating multidimensional information such as patients' demographic, clinical, and omics data (including DNA genotyping, whole-exome sequencing, transcriptome sequencing, etc.), it prioritizes standard treatment plans and recommends the optimal personalized treatment plan. Including targeted drugs, chemotherapy, immunotherapy approved by China CDE.

Also known as: KEYTRUDA et al.

Quasar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in the clinical study, fully understand and be informed about the study, sign the informed consent form, and be willing and able to comply with and complete all trial procedures.
• Aged ≥18 years, no gender restrictions.
• Patients with advanced or metastatic malignant tumors confirmed by histology or cytology.
• Able to provide tumor tissue and peripheral blood samples for multi-omics testing, or able to provide qualified whole-exome sequencing and transcriptomics data.

You may not qualify if:

• As assessed by the investigator, no standard treatment is available, or the patient is unsuitable for guideline-recommended anti-tumor therapies.
• Other conditions deemed unsuitable for participation in this study by the investigator.

Sponsors & Collaborators

• NING LI: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Langfang Branch)

Langfang, Hebei, China

Location

Study Officials

• Shuhang Wang, PhD

  National Cancer Center of China

  STUDY DIRECTOR

Central Study Contacts

Ning LI, M.D.

CONTACT

+86 (010) 8778-8165; lining@cicams.ac.cn

Yale JIANG, M.D.

CONTACT

+86 (010) 8778-8713; yalejiang@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director of Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 28, 2030
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)