RMC-9805 in KRAS G12D-Mutant Solid Tumors

Phase 1/1b descriptive safety/tolerability primary endpoint (TEAEs/SAEs/DLTs) in open-label design—these characterization endpoints succeed at very high base rates (~90%+). RMC-9805 tolerability in Revolution's G12D program has been clean to date. Main risk is timing slippage given still-recruiting status, not endpoint failure.

Phase 1/1b dose-escalation with descriptive safety/tolerability primary endpoint (TEAEs, SAEs, DLTs). Such endpoints have very high base rate of being met as they require reportable safety data rather than efficacy thresholds. RMC-9805 early profile has been manageable per disclosures. Main risk is operational: still recruiting 10 days from PCD suggests possible PCD slippage, but endpoint resolution remains likely positive.

Primary endpoint is TEAE/SAE/DLT characterization, a descriptive Ph1 safety readout with ~90%+ base-rate completion; it is not a pass/fail efficacy bar. RMC-9805 mono and combo with RMC-6236 have already produced manageable safety disclosures from RVMD. Trial still recruiting with PC in 10 days; minor residual risk from delay or premature termination, not outright endpoint miss.

Phase 1 safety/tolerability endpoint is typically met unless major toxicity emerges. Open-label design and standard DLT metrics make success highly likely barring unexpected safety issues.

Phase 1 primary endpoint is safety/tolerability, which is typically met unless severe toxicity emerges. Standard design and broad oncology population reduce risk of failure.

Phase 1 safety/tolerability endpoint is typically achievable unless major toxicity emerges. Standard oncology dose-escalation design with low bar for success supports high probability.

Ph1/1b open-label trial with standard safety/tolerability primary (TEAEs/SAEs/DLTs). Typical advanced KRAS G12D solid tumor (NSCLC/CRC/PDAC) population. Experienced sponsor in RAS inhibitors. Near primary completion after recruiting. Interim prior data show no DLTs, MTD unreached, mostly Gr1/2 GI AEs, RP2D selected supporting high likelihood of success.

Phase 1/1b open-label study in advanced KRAS G12D-mutant solid tumors with primary endpoint focused on safety/tolerability (TEAEs, SAEs, DLTs). Standard dose-escalation design typically identifies manageable RP2D in oncology. Selective KRAS G12D(ON) mechanism likely limits off-target toxicity. Experienced sponsor, multicenter execution, and clear endpoint metrics support high success odds with low

Phase 1/1b open-label multicenter trial with primary endpoint of safety/tolerability (TEAEs, SAEs, DLTs) standard for dose escalation in advanced KRAS G12D-mutant solid tumors. Recruiting status and 10 days to primary completion indicate on-track operational execution. Endpoint quality high for observable toxicities; design allows clear determination of tolerable dose with low disclosure risk.

Interim data presentations from EORTC 2024 and AACR 2025 have already confirmed an acceptable safety and tolerability profile for RMC-9805. No dose-limiting toxicities or Grade 4/5 TRAEs were observed, and an RP2D of 1200 mg was established. Successfully characterizing safety and finding a tolerable dose means the primary safety endpoint of this Phase 1/1b trial is effectively met.

The primary endpoint is safety and tolerability. Revolution Medicines recently presented updated Phase 1 data at AACR in April 2026, establishing an RP2D of 1200mg QD with a favorable safety profile, minimal TRAEs, and no DLTs. Because safety was successfully characterized, the trial has met its primary objective.

Phase 1 trials evaluating safety inherently meet their primary endpoint unless terminated early for extreme toxicity. RVMD already presented clinical data for RMC-9805 showing no DLTs, an acceptable safety profile, and established a recommended Phase 2 dose. This confirms the trial's safety evaluation objectives are fully achieved and ensures a YES resolution.

Phase 1/1b primary endpoint is safety/tolerability, which is often met for monotherapy and well-tolerated combinations. Sponsor has KRAS expertise. Low bar for success, but combination could introduce new toxicities. Recruitment ongoing near completion date is a minor operational risk.

Phase 1/1b primary endpoint is safety/tolerability. Sponsor has strong KRAS-targeting track record. Early clinical data for related assets supportive. Safety endpoints in dose-finding studies typically met, but small sample and combo arm add some uncertainty.

Phase 1/1b primary endpoint is safety/tolerability, a low bar often met. Sponsor is experienced. However, KRAS G12D is a challenging target, and combination arm adds complexity. High likelihood of meeting safety endpoint.

Phase 1/1b safety endpoints have a high historical success rate due to flexible dose escalation designs. RMC-9805 is a KRAS G12D inhibitor following validated clinical strategies. With only 10 days to primary completion, the safety database is likely mature, minimizing execution risk.

Primary endpoint is safety/tolerability in a Phase 1 dose-escalation study. These endpoints historically have >90% success rates as they measure toxicity, not efficacy. KRAS G12D inhibitors have shown manageable safety profiles in similar trials. Only catastrophic toxicity would cause failure; 10 days to completion suggests data is mature.

Phase 1 safety endpoints in oncology have a high historical success rate (>90%). The trial focuses on safety and tolerability for RMC-9805, a KRAS G12D inhibitor. With primary completion in 10 days, the database is likely locked. Low risk of failure unless unexpected late toxicities emerge.

Phase 1/1b trial with focus on safety and tolerability, open-label design, and small time to primary completion.

Phase 1/1b trial with focus on safety and tolerability, open-label design, and small time to primary completion.

Phase 1/1b trial with focus on safety and tolerability, primary endpoint achievable

Phase 1/1b safety endpoint with 10 days to completion. Safety/tolerability endpoints in dose-escalation trials typically resolve YES as standard dose-finding achieves acceptable safety profile. Sponsor RVMD has strong KRAS inhibitor track record (RMC-6236). Open-label design with no control arm reduces execution risk. Primary completion imminent suggests data already collected or near-final.

Phase 1/1b safety trials have high success rates (~70-80%) as primary endpoints are typically met. RMC-9805 is a promising KRAS G12D inhibitor with strong preclinical data. 10 days to completion suggests enrollment near done. Safety endpoints are achievable; Revolution Medicines has operational track record. Disclosure risk minimal with imminent readout.

Phase 1/1b safety endpoints are typically achievable with well-designed dose escalation. RMC-9805 is a RAS(ON) inhibitor with mechanistic rationale; Revolution Medicines has strong RAS inhibitor platform credibility. Primary completion in 10 days suggests enrollment complete and safety data mature. Safety/tolerability endpoints rarely fail in dose-escalation designs unless unexpected severe toxicity emerges, which is uncommon with experienced sponsors. 65% intrinsic probability reflects modest residual uncertainty about combination arm safety.

Phase 1 safety/tolerability trials almost universally meet their primary endpoints by design. They start at low doses, have DSMB oversight, and only stop if unexpected severe toxicity occurs. With only 10 days to primary completion, the trial is near completion with high likelihood of meeting the safety endpoint.

Phase 1 safety/tolerability trials have high success rates (>75%) as they're designed to establish MTD. The endpoint is safety-focused, not efficacy. However, only 10 days to primary completion with status still 'Recruiting' introduces execution uncertainty. Market prices 72% which is roughly aligned.

Phase 1 safety/tolerability endpoints have historically high success rates. The trial is testing RMC-9805 in KRAS G12D-mutant solid tumors with only 10 days to primary completion. Early-phase oncology trials focused on safety typically meet their endpoints. The open-label design and experienced sponsor (RVMD) support execution feasibility.