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

Real-world Study to Investigate Optimal Standard Treatment Selection for Solid Tumor Patients by Guided by Biologically-informed Multi-agent System

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE.

Detailed Description

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. The study will prospectively collect patient data of multiple dimensions, including demographics, clinical information (pathological classification, tumor staging, imaging findings, previous treatment regimens and their effectiveness, performance status scores), and multi-omics data (DNA gene panel testing, whole-exome sequencing, transcriptome sequencing, etc.). 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. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ning LI, M.D.; Phone Number: +86 (010) 8778-8165; Email: lining@cicams.ac.cn
• Study Contact Backup: Name: Yale JIANG, M.D.; Phone Number: +86 (010) 8778-8713; Email: yalejiang@cicams.ac.cn

Study Locations

• China
  • Hebei
    • Langfang, Hebei, China
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Langfang Branch)
      • Contact: Ning LI, M.D.; Phone Number: +86 (010) 8778 8165; Email: lining@cicams.ac.cn
      • Contact: Yale JIANG, M.D.; Phone Number: +86 (010) 8778 8165; Email: yalejiang@cicams.ac.cn
      • Contact: Ning LI, M.D.
      • Contact: Yale JIANG, M.D.
      • Contact: Shuhang Wang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Quasar; 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.; 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.; Other Names: KEYTRUDA et al.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Defined as the proportion of cases showing the best response of complete response (CR) or partial response (PR) (i.e., CR+PR) per RECIST 1.1 (based on CT, MRI or PET-CT), during the period from the start of the investigational drug to withdrawal from the trial.	Every 6 weeks, up to 2 years since enrollment
Duration of response (DoR)	Defined as the time from the first documented response, i.e. CR or PR, per RECIST 1.1, to disease progression or death from any cause, whichever occurs first.	Every 6 weeks, up to 2 years since enrollment
Time to treatment failure (TTF)	Defined as the time from the start of enrollment to the termination of treatment for any reason, including disease progression per RECIST 1.1, treatment toxicity, or death.	Every 6 weeks, up to 2 years since enrollment
Time to progression (TTP)	Defined as the time from enrollment to the occurrence of objective tumor progression per RECIST 1.1, excluding death.	Every 6 weeks, up to 2 years since enrollment
Best of response (BoR)	Defined as the best therapeutic effect recorded from the start of treatment until disease progression or recurrence, per RECIST 1.1.	Every 6 weeks, up to 2 years since enrollment
Treatment-emergent adverse events (TEAE)	Defined as adverse events that emerge or worsen in severity following the initiation of intervention, per CTCAE 5.0.	Every 6 weeks, up to 2 years since enrollment

Collaborators and Investigators

• Sponsor: NING LI
• Investigators: Study Director: Shuhang Wang, PhD, National Cancer Center of China

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Advanced Solid Tumors; Multi-omics; Real World Study; Standard Treatment
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Protein Kinase Inhibitors; Osimertinib; Pemetrexed; Pembrolizumab
• Other Study ID Numbers: SINGULARITY-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes