Worksheet — CRC Targeted-Therapy Phase 2 Duration Benchmark

Summary
Question: which companies have run targeted-therapy Phase 2 trials in colorectal cancer, and how long do those studies take?
Answer: across the 14 CRC-dedicated targeted-therapy Phase 2 trials below, a study averages ~37 months and ~117 patients, enrolling at ~3.4 patients/month. Industry-sponsored trials run faster (~4–5 patients/month; 18–57 months); small academic re-challenge trials are slower. For a plixorafenib BRAF V600E CRC Phase 2, the closest comparators (SWOG S1406, encorafenib+cetuximab) point to ~35–40 months and ~100–160 patients.
Note: the “mo/1,000” column further down is only a size-normalized figure for comparing trials of different sizes — it is not a real timeline.

~37 months

average study duration (range 16–57)

~117

average patients enrolled

~3.4 / mo

average enrollment pace (patients / month)

CRC-dedicated trials analyzed

🧮 Plan your study vs the benchmark

N = patients over months

CRC-dedicated trials — click any column header to sort

Trial	Sponsor	Target	Phase	N	Dur (mo)	mo/1k	pts/mo	Setting	Src
KRYSTAL-10	Mirati/BMS Ind	KRAS G12C	3	461	54	117	8.5	2L mCRC	CT.gov
DESTINY-CRC02	Daiichi Sankyo Ind	HER2	2	122	20	164	6.1	≥2L	CT.gov
DESTINY-CRC01	Daiichi / AstraZeneca Ind	HER2	2	86	18	209	4.8	≥2L	CT.gov
Encorafenib + cetuximab	Pfizer / Array Ind	BRAF+EGFR	1b/2	156	35	224	4.5	2L+	CT.gov
Fruquintinib + sintilimab	CAMS Aca	VEGFR/PD-1	2	70	16	229	4.4	3L	CT.gov
ReDOS	NCI / academic Coop	regorafenib	2	123	29	236	4.2	≥3L	CT.gov
CodeBreaK 300	Amgen Ind	KRAS G12C	3	160	39	244	4.1	≥2L	CT.gov
SWOG S1406	SWOG Coop	BRAF+EGFR	2	106	36	340	2.9	1–2 prior	CT.gov
MOUNTAINEER	Seagen Ind	HER2	2	117	57	487	2.1	≥3L	CT.gov
CAVE	Vanvitelli Aca	EGFR rechallenge	2	77	39	506	2.0	3L	CT.gov
CHRONOS	Piemonte Aca	EGFR ctDNA rechallenge	2	32	25	781	1.3	3L	CT.gov
Glecirasib + cetuximab	Jacobio Ind	KRAS G12C	1/2	48	38	792	1.3	2L+	CT.gov
CRICKET	GONO Aca	EGFR rechallenge	2	27	33	1222	0.8	3L	CT.gov
HERACLES (soft)	Piemonte Aca	HER2	2	54	76	1407	0.7	≥3L	CT.gov

Fore anchor (BRAF V600E CRC): your closest comparators are SWOG S1406 (106 pts / 36 mo / 340) and the encorafenib+cetuximab doublet (156 pts / 35 mo / 224) — plan ~35–40 months, ~100–160 patients, ~3–4.5 pts/month. The HER2 T-DXd studies (18–20 mo) show the fast end when the biomarker population is accessible and the sponsor is well-resourced.

Excluded (basket / master-protocol — N spans many tumor types, not CRC-specific): MyPathway, CodeBreaK 101, KRYSTAL-1, divarasib GO42144, RMC-6236, NAVIGATE, STARTRK-2. BEACON CRC excluded (Phase 3; 30-pt Ph2 lead-in only).

Data quality: all durations/enrollment from ClinicalTrials.gov. Actuals: KRYSTAL-10, DESTINY-CRC01/02, encorafenib (NCT01719380), CodeBreaK 300, glecirasib, ReDOS, SWOG S1406, CHRONOS, CRICKET, CAVE. Estimated (still active): fruquintinib+sintilimab. HERACLES enrollment/dates are soft (aggregated cohorts). CodeBreaK 300 & KRYSTAL-10 are Phase 3 (kept as CRC-dedicated context). Every trial links to its ClinicalTrials.gov record above.

Sources & references

Single source. Every figure in this worksheet — enrollment, duration, and the derived pace and mo/1,000 columns — is taken from the ClinicalTrials.gov registration records listed below. No publication was used to derive any number here. Records retrieved 2026-07-09 via the ClinicalTrials.gov API v2 and reconciled against the benchmark table above.

Trial	Lead sponsor	Phase	Enrollment	Registry status	Record
CAVE	University of Campania Luigi Vanvitelli	Phase 2	77 (actual)	Completed	NCT04561336
CHRONOS	Fondazione del Piemonte per l'Oncologia	Phase 2	32 (actual)	Completed	NCT03227926
CodeBreaK 300	Amgen	Phase 3	160 (actual)	Completed	NCT05198934
CRICKET	Gruppo Oncologico del Nord-Ovest	Phase 2	27 (actual)	Unknown	NCT02296203
DESTINY-CRC01	Daiichi Sankyo Co., Ltd.	Phase 2	86 (actual)	Completed	NCT03384940
DESTINY-CRC02	Daiichi Sankyo	Phase 2	122 (actual)	Completed	NCT04744831
Encorafenib + cetuximab	Pfizer	Phase 2	156 (actual)	Completed	NCT01719380
Fruquintinib + sintilimab	Aiping Zhou	Phase 2	70 (estimated)	Unknown	NCT04695470
Glecirasib (JAB-21822)	Allist Pharmaceuticals, Inc.	Phase 1/Phase 2	48 (actual)	Active Not Recruiting	NCT05194995
HERACLES	Fondazione del Piemonte per l'Oncologia	Phase 2	54 (estimated)	Unknown	NCT03225937
KRYSTAL-10	Mirati Therapeutics Inc.	Phase 3	461 (actual)	Active Not Recruiting	NCT04793958
MOUNTAINEER	Seagen Inc.	Phase 2	117 (actual)	Completed	NCT03043313
ReDOS	Academic and Community Cancer Research United	Phase 2	123 (actual)	Completed	NCT02368886
SWOG S1406	SWOG Cancer Research Network	Phase 2	106 (actual)	Completed	NCT02164916

Note on enrollment. Actual counts are final; estimated counts are the sponsor's target and will move — both are labelled per record. Registry status is the sponsor's own last update, so “Unknown” means the record has gone stale (CRICKET, HERACLES), not that the trial is missing. HERACLES enrollment is an estimate across aggregated cohorts, which is why its figures are marked soft above. Verify against the live record before use in filings.