Clinical Trials
Unified view of 14 clinical trials across 6 molecules in the Mays Cancer Center oncology portfolio — with trial prediction and competitive analysis.
14
Total Trials
5
Active Trials
6
Molecules
1,524
Patients Enrolled
1,880
Target Enrollment
Trial Prediction & Success Probability
Estimated approval probability based on phase, modality, FDA designations, and clinical data strength
CTCL / PTCL · Phase 1/2
Next Milestone
Phase 2 expansion cohort readout
Timeline: 12–18 months
Accelerators
- FDA Fast Track + Orphan Drug designations
- Platelet-sparing advantage over navitoclax
Risk Factors
- Novel PROTAC modality — no oncology regulatory precedent
- Small biotech sponsor with limited resources
Recurrent GBM · Phase 2
Next Milestone
Phase 2 primary endpoint readout (OS)
Timeline: 6–12 months
Accelerators
- FDA Fast Track + Orphan Drug + RMAT designations
- Breakthrough OS data (22.9mo vs 5.6mo historical)
Risk Factors
- Single-arm trial — may face regulatory scrutiny
- CED procedure limits scalability
Recurrent GBM · Phase 2
Next Milestone
Phase 2 interim analysis
Timeline: 18–24 months
Accelerators
- Proven ADC platform (FDA-approved in TNBC and UC)
- Phase 0 CNS PK data supports brain penetration
Risk Factors
- BBB penetration uncertainty for ADC
- Trop-2 expression variability in GBM
Advanced solid tumors · Phase 1a/1b
Next Milestone
First patient dosed (Feb 2026) → dose escalation
Timeline: 24 months
Accelerators
- SIRPα/CD47 axis validated by magrolimab data
- BioSion partnership with clinical expertise
Risk Factors
- First-in-class anti-SIRPα — no clinical precedent
- Immune checkpoint combination needed for monotherapy gaps
mCRPC (pre-chemo) · Approved (label expansion)
Next Milestone
PSMAddition readout (mHSPC expansion)
Timeline: Active
Accelerators
- Only civilian center in South Texas
- PSMAfore label expansion doubles TAM
Risk Factors
- 177Lu supply constraints
- Next-gen RLTs (225Ac-PSMA) may erode market
Enrollment Progress
Target vs actual enrollment across all portfolio trials
Competitive Trial Landscape
External trials competing in the same indications as Mays portfolio molecules
Competitive Positioning — Efficacy vs Safety Differentiation
Mays portfolio molecules shown in color · Competitors in gray · Bubble size reflects development maturity
| Competitor | Sponsor | Phase | Indication | Threat | Mays Advantage |
|---|---|---|---|---|---|
Delta-24-RGD (DNX-2401) Oncolytic virus · Tumor-selective adenoviral replication | DNAtrix | Phase 2 | Recurrent GBM | medium | 186RNL shows superior median OS (22.9mo) with theranostic imaging |
Olutasidenib (Rezlidhia) Small Molecule · IDH1 R132H | Rigel Pharmaceuticals | Approved (AML); Phase 2 GBM | IDH1-mutant glioma | low | 186RNL targets all GBM, not just IDH1-mutant (~10% of GBM) |
CAN-3110 Oncolytic virus · HSV-1 oncolytic | Candel Therapeutics | Phase 1 | Recurrent high-grade glioma | low | 186RNL has more advanced clinical data with Phase 2 near completion |
Navitoclax (ABT-263) Small Molecule · BCL-XL/BCL-2 | AbbVie | Phase 3 | Myelofibrosis | high | DT2216 PROTAC spares platelets — navitoclax causes severe thrombocytopenia |
Pelcitoclax (APG-1252) Small Molecule · BCL-2/BCL-XL | Ascentage Pharma | Phase 1/2 | SCLC / Hematologic malignancies | low | DT2216 catalytic degradation achieves full target engagement vs occupancy-based inhibition |
225Ac-PSMA-617 Alpha-emitting RLT · PSMA | Various academic | Phase 1/2 | mCRPC | high | Pluvicto is FDA-approved now; 225Ac years from approval + supply issues |
PNT2002 (177Lu-PSMA-I&T) RLT · PSMA | POINT Biopharma / Eli Lilly | Phase 3 | mCRPC (pre-chemo) | medium | Pluvicto has first-mover advantage with label + reimbursement established |
Magrolimab (5F9) mAb · CD47 | Gilead Sciences | Phase 3 (discontinued) | AML / MDS | low | BSI-082 anti-SIRPα avoids red blood cell toxicity that doomed magrolimab |
Evorpacept (ALX148) Fusion protein · CD47 (decoy receptor) | ALX Oncology | Phase 2/3 | MDS / AML | medium | BSI-082 targets SIRPα directly — avoids antigen sink on RBCs |
Oncology Phase Transition Success Rates
Historical success rates for oncology drug development (BIO/QLS analysis) vs Mays portfolio positioning
Avg. 2.0 years
2 Mays trials
Avg. 2.8 years
1 Mays trial
Avg. 3.2 years
2 Mays trials
Avg. 3.5 years
Avg. 1.3 years
All Clinical Trials
Filter by molecule, phase, or status across all 6 portfolio molecules
| Trial | Molecule | Phase | Status | Indication | Enrollment | PI |
|---|---|---|---|---|---|---|
NCT04886622 Phase 1 Dose Escalation Study of DT2216 in Patients With Relapsed/Refractory Malignancies | dt2216 | Phase 1 | Recruiting | T-cell lymphoma (CTCL/PTCL) | 42 / 60 | Dr. Daruka Mahadevan |
dt2216-ph1-2-expansion Phase 1/2 Expansion of DT2216 at RP2D in Hematologic Malignancies | dt2216 | Phase 1/2 | Recruiting | Hematologic malignancies (CTCL, PTCL, AML/MDS) | — / 90 | Dr. Daruka Mahadevan |
NCT01906385 ReSPECT Phase 1: Dose Escalation Study of 186RNL via Convection-Enhanced Delivery in Recurrent GBM | 186rnl | Phase 1 | Completed | Recurrent glioblastoma (rGBM) | 55 / 55 | Dr. Andrew Brenner |
NCT04262466 ReSPECT-GBM Phase 2: 186RNL via CED in Recurrent Glioblastoma | 186rnl | Phase 2 | Recruiting | Recurrent glioblastoma (rGBM) | 22 / 31 | Dr. Andrew Brenner |
NCT05765006 ReSPECT-LM Phase 1: 186RNL for Leptomeningeal Metastases | 186rnl | Phase 1 | Recruiting | Leptomeningeal metastases | 8 / 18 | Dr. Andrew Brenner |
NCT06528080 ReSPECT-PBT Phase 1: 186RNL for Pediatric Brain Tumors | 186rnl | Phase 1 | Not Yet Recruiting | Pediatric brain tumors | — / 24 | Dr. Andrew Brenner |
186rnl-respect-gbm2 ReSPECT-GBM2: Multicenter Phase 2 Expansion of 186RNL in Recurrent GBM | 186rnl | Phase 2 | Not Yet Recruiting | Recurrent glioblastoma (rGBM) | — / 126 | Dr. Andrew Brenner |
NCT00894894 Phase 1 Dose-Finding Study of Amuvatinib (MP-470) in Patients With Advanced Solid Tumors | amuvatinib | Phase 1 | Completed | Advanced solid tumors | 21 / 25 | Dr. Daruka Mahadevan |
NCT01357395 Phase 1b/2 Study of Amuvatinib (MP-470) in Combination With Erlotinib in Patients With Advanced NSCLC | amuvatinib | Phase 1/2 | Completed | Non-small cell lung cancer (NSCLC) | 37 / 40 | Dr. Daruka Mahadevan |
NCT03995706 Phase 0 Study of Sacituzumab Govitecan in Recurrent Glioblastoma to Evaluate Drug Delivery | sacituzumab-gbm | Phase 0 | Completed | Recurrent Glioblastoma | 12 / 12 | Dr. William Kelly |
NCT04559230 Phase 2 Study of Sacituzumab Govitecan in Trop-2 Positive Recurrent Glioblastoma | sacituzumab-gbm | Phase 2 | Recruiting | Recurrent Glioblastoma (Trop-2 positive) | 28 / 40 | Dr. William Kelly |
bsi082-ph1a-mono Phase 1a/1b Study of BSI-082, an Anti-SIRPα Monoclonal Antibody, in Advanced Solid Tumors as Monotherapy and in Combination with Trastuzumab Deruxtecan (T-DXd) | bsi-082 | Phase 1 | Not Yet Recruiting | Advanced solid tumors; HER2+ breast cancer (combo arm) | — / 60 | Dr. John Sarantopoulos |
NCT03511664 VISION: A Phase 3, Randomized, Open-Label Study of 177Lu-PSMA-617 in mCRPC Previously Treated With ARPI and Taxane Chemotherapy | pluvicto | Phase 3 | Completed | mCRPC (post-ARPI, post-taxane) | 831 / 831 | Dr. Oliver Sartor |
NCT04689828 PSMAfore: A Phase 3 Study of 177Lu-PSMA-617 vs Change of ARPI in PSMA-Positive mCRPC | pluvicto | Phase 3 | Completed | mCRPC (post-ARPI, pre-chemotherapy) | 468 / 468 | Dr. Karim Fizazi |
Showing 14 of 14 trials