Cost Analysis Results

Most granular public information comes from the ClinicalTrials.gov record plus two hospital recruitment pages that outline patient-facing logistics.
All sources agree the first 21-day dose-escalation (“DLT”) cycle requires intensive pharmacokinetic and safety monitoring with clinic visits on Days 1, 2, 8 and 15, in addition to a pre-study screening visit and an end-of-cycle evaluation.
For patients who continue beyond Cycle 1, both the protocol synopsis on the sponsor site and hospital listings state that clinic assessments occur on Day 1 of every subsequent 21-day cycle, with imaging every two cycles; expansion-phase subjects are expected to remain on treatment ~12 months unless they progress earlier.
Using these details we estimate 5-7 scheduled visits in the initial Dose-Exploration phase and 15-19 visits over 12 expansion cycles, giving mid-point estimates of 6 and 17 respectively.
No tele-health–only visits are mentioned; all listed encounters are assumed in-person.

Narrative summary
RMC-6236-001 is an open-label Phase 1/1b first-in-human oncology trial evaluating an oral RAS-MULTI(ON) inhibitor in adults with advanced solid tumours carrying specific RAS mutations. According to the ClinicalTrials.gov record and a 2Q-2024 Revolution Medicines corporate deck, the study:

• uses a standard 3 + 3 dose-escalation followed by multiple parallel expansion cohorts;
• plans ~614 participants but currently lists 16 U.S. academic / high-throughput cancer centres only; no ex-US countries have been opened to date;
• requires frequent safety labs, intensive plasma PK profiling through Week 15, and CT/MRI tumour assessments every 8 weeks through treatment and for 30 days after the last dose; no mandatory fresh tumour biopsies are specified;
• has an overall treatment plus follow-up window of ≈2.5 years (long for Phase 1 oncology);
• mandates documented KRAS/NRAS/HRAS mutations, adding moderate screening complexity.

Cost-driver comparison vs. typical Phase 1 solid-tumour trials (usually ≤10 sites, 12-18 month duration, similar PK and imaging schedules) therefore shows:

Complex procedures – comparable (routine blood PK, imaging);
Sites/Countries – modest number and single-country footprint;
Study duration – somewhat longer than norm;
Monitoring & data demands – standard for oncology.

Overall, operational cost is estimated MEDIUM within Phase 1 Oncology.

Estimated scheduled on-site visits per patient
• Screening (1)
• Cycle 1 weekly visits Days 1, 8, 15, 22 (4)
• Cycle 2 Days 1 & 15 (2)
• Cycles 3-6 Day 1 every 28 days (4)
• Imaging/End-of-Tx ~q8w overlaps with Day 1 visits
• Safety follow-up 30 days post last dose (1)
≈12 in-person visits during the first 24 weeks; patients continuing beyond 6 cycles would add monthly visits.

Analysis
Key cost-driver assumptions
• Dose & regimen: Final recommended phase-2 dose expected at ~150 mg orally once daily. Tablets manufactured at 50 mg strength; average patient takes 3 tablets/day.
• Treatment duration: Median on-treatment exposure in phase-1/1b oncology trials ≈ 4 months (120 days).
• Enrollment: 614 evaluable patients.
• Overage: 25 % added to cover screen failures, early discontinuations, shipping losses, and expiry.
• Total API required = 150 mg × 120 days × 614 pts × 1.25 overage = 16.6 kg.
• API cost: First-generation GMP route for a synthetically complex, small-molecule RAS inhibitor budgeted at USD 20,000/kg (mid-range of USD 15k–30k/kg typical for low-tens-kg scale). API cost ≈ 20,000 × 16.6 kg = USD 332 k.
• Formulation: Direct compression into film-coated 50 mg tablets; 30 tablet HDPE bottles. Total tablets = 3 tabs/day × 120 days × 614 pts × 1.25 = 276,000. Small-scale CMO price (tableting, coating, in-process controls) budgeted at USD 0.30/tab → USD 83 k.
• Packaging/labeling: 30-count bottles; 276,000 ÷ 30 = 9,200 bottles, each USD 2.00 (printed label, booklet leaflet, tamper-evident seal) → USD 18 k.
• Release & stability testing: Five GMP batches anticipated; USD 15 k/batch analytical release + USD 5 k/batch stability initiation → USD 100 k total.
• Depot storage & distribution: Ambient product; global 3PL depot at USD 2 k/mo for 48 months = USD 96 k. Site resupply logistics: ~240 temperature-monitored shipments at USD 200 each = USD 48 k.
• Project management / QP release / regulatory documentation: 10 % of direct CMC spend = USD 68 k.

Cost build-up (USD, rounded):
API 332 k
Tableting 83 k
Packaging/labeling 18 k
Analytical & stability 100 k
Depot storage 96 k
Distribution 48 k
CMC PM/QP 68 k
Expected total ≈ 745 k.

Range:
Low case (75 mg RP2D, 15 k/kg API, shorter 3-month median exposure) ≈ 380 k.
High case (300 mg RP2D, 30 k/kg API, 6-month median exposure, extra stability lots) ≈ 1.5 M.

This Phase 1/1b study is single-arm and open-label: every enrolled patient receives the investigational agent RMC-6236, with no active control, placebo, or sham procedure specified. Because no comparator product needs to be procured, packaged, blinded, stored, or shipped, the entire comparator-supply budget is zero.

Based on the analysis, this study falls under oncology therapeutic area.

This tool estimates clinical trial costs using established academic methodologies and real-world data sources:

Accuracy: The methodology typically estimates within 60-160% of actual costs and provides a systematic approach for investment analysis and business planning.