Trial Partnership Targets
One trial per category — high impact, groundbreaking, save-the-trial — with PANDA module mapping.
| Category | Trial | Pitch angle |
|---|---|---|
| High Impact | RASolute 302NCT06625320 | Largest mPDAC survival win ever; co-develop PANDA as the central read engine for follow-on combo and earlier-line studies |
| Groundbreaking | IMCODE003NCT05968326 | Adjuvant DFS is investigator-determined across global sites — PANDA Surveillance + Pathology Normalization protects the endpoint at scale |
| Save the Trial | ElraglusibNCT03678883 | Phase 2 OS hit; PFS/ORR missed due to open-label bias — PANDA provides blinded BICR-grade RECIST for Phase 3 registrational integrity |
RASolute 302 — Daraxonrasib (RMC-6236) vs investigator's choice
Primary Endpoint
PFS and OS in RAS G12-mutant population; PFS by BICR per RECIST 1.1
PANDA Modules
Pitch Angle
Largest mPDAC survival win ever; co-develop PANDA as the central read engine for follow-on combo and earlier-line studies
Where PANDA Fits
Primary endpoint is BICR per RECIST 1.1 — Patient Review + EUS AI engine. Automated lesion segmentation, κ-tracked inter-reader agreement (0.81), disease-burden trajectory by arm, audit-ready discordance flags. Cohort Builder pre-screens by RAS mutation + measurable disease + ECOG 0–1.
Inclusion Criteria
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed PDAC with metastatic disease.
- Measurable disease per RECIST 1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation)
- Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
- Able to take oral medications.
Exclusion Criteria
- Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
- History of or known central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study treatment
- Major surgery within 4 weeks prior to randomization.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures
IMCODE003 — Autogene Cevumeran (mRNA neoantigen vaccine)
Primary Endpoint
Disease-Free Survival (DFS) — time from randomization to first recurrence or death, investigator-determined
PANDA Modules
Pitch Angle
Adjuvant DFS is investigator-determined across global sites — PANDA Surveillance + Pathology Normalization protects the endpoint at scale
Where PANDA Fits
Investigator-determined DFS is the weak spot — Surveillance module for continuous post-resection CT/MRI burden tracking, κ-tracked agreement between local and central reads, CA 19-9 + imaging composite trajectories. Pathology Normalization harmonizes R0/R1 across 200+ global sites.
Inclusion Criteria
- Histologically confirmed diagnosis of PDAC
- TNM pathological staging T1-T3, N0-N2, M0 (resectable, non-metastatic)
- Macroscopically complete resection of PDAC (R0 or R1)
- Unequivocal absence of disease after surgery
- CA 19-9 level measured within 14 days prior to treatment
- Interval of 6-12 weeks since resection of PDAC
- Adequate hematologic and end-organ function
- ECOG performance status 0 or 1
Exclusion Criteria
- Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
- Absence of spleen or distal pancreatectomy with splenectomy
- Pre-existing Grade >= 2 neuropathy
- Known DPD deficiency (DPYD mutations)
- Active or history of autoimmune disease or immune deficiency
- Pregnancy or breastfeeding
- Patient deceased
Elraglusib — Actuate-1801 Part 3β (GSK-3β inhibitor)
Primary Endpoint
1-year survival rate; secondary: mOS, DCR, ORR, PFS
PANDA Modules
Pitch Angle
Phase 2 OS hit; PFS/ORR missed due to open-label bias — PANDA provides blinded BICR-grade RECIST for Phase 3 registrational integrity
Where PANDA Fits
Phase 2 OS hit (HR 0.62) but PFS/ORR missed due to open-label reader variability. PANDA delivers BICR-quality RECIST adjudication with κ tracking, disease-burden trajectory, blinded central read pipeline for open-label bias mitigation, EUS/imaging consensus for baseline staging.
Inclusion Criteria
- Age >= 18 years
- Pathologically confirmed metastatic pancreatic cancer
- Treatment-naive for metastatic disease (no prior systemic agents in metastatic setting)
- At least 1 measurable lesion per RECIST 1.1
- Adequate bone marrow function (ANC >= 500, Hgb >= 8.5, platelets >= 75000)
- Adequate liver function (AST/ALT <= 3x ULN)
- Adequate renal function (CrCl >= 30 mL/min)
- ECOG performance status 0 or 1
Exclusion Criteria
- Pregnancy or lactation
- Endocrine or acinar pancreatic carcinoma
- Significant cardiovascular impairment (CHF > NYHA Class II, unstable angina, stroke within 6 months)
- Symptomatic brain metastases or leptomeningeal disease
- Major surgery within 7 days
- Current active malignancy other than pancreatic
- Patient deceased
Trial data sourced from ClinicalTrials.gov. Pitch angles and PANDA fit assessments are internal — not endorsed by trial sponsors. For CTO conversation use only.