Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in colorectal cancer
- New trial
Colorectal cancer
Phase 1 Ad5.F35-hGUCY2C-PADRE + Lm-GUCY2C vaccines, GUCY2C-targeted T-cell immunotherapy
This open-label, non-randomized Phase 1 dose-escalation study at Thomas Jefferson University tests a heterologous prime-boost cancer vaccine strategy targeting GUCY2C, an intestinal lineage antigen commonly retained…
NCT07417488 First-in-human - New trial
Colorectal cancer
Phase 2 botensilimab Fc‑enhanced anti‑CTLA‑4 + balstilimab PD‑1 antibody in MSS colon cancer
City of Hope Medical Center is running this Phase 2 neoadjuvant study (NEST3) testing whether short-course dual checkpoint blockade—botensilimab (a next‑generation, Fc‑enhanced anti‑CTLA‑4 monoclonal antibody) plus…
NCT07595874 Exploratory - Trial result
Colorectal cancer
Prolonging nCRT→TME interval to 12 weeks fails to boost pCR in stage II–III rectal cancer (RCT)
Long-course neoadjuvant chemoradiotherapy (50Gy with concurrent 5-fluorouracil) followed by total mesorectal excision (TME) was tested in an RCT of locally advanced rectal cancer (MRI-staged stage II–III…
NCT03607370 - New trial
Colorectal cancer
Phase 1 S-adenosylmethionine (SAMe) methyl-donor supplement to modulate epigenetics/microbiome
This first-in-human, single-center, open-label Phase 1 dose-finding study tests daily oral S-adenosylmethionine (SAMe)—the body’s principal methyl-group donor used in cellular methylation reactions—as a potential…
NCT07582003 First-in-human - New trial
Colorectal cancer
Phase 1b DCSZ11 CD93-directed monoclonal antibody adds tumor-vasculature immunotherapy to TNT.
This Johns Hopkins–led Phase 1b, open-label total neoadjuvant therapy study evaluates safety and preliminary activity of DCSZ11 (a CD93-directed monoclonal antibody) combined with short-course radiation plus CAPOX…
NCT07580339 Exploratory - Trial result
Colorectal cancer
FOLFOXIRI (triplet chemo) + capecitabine-RT delivers 20.5% pCR in high-risk LARC
Modified FOLFOXIRI (5-FU/leucovorin, oxaliplatin, irinotecan) induction chemotherapy was tested as part of a Phase II, multicenter, single-arm total neoadjuvant approach in Chinese patients with high-risk,…
NCT01941641 - New trial Spotlight
Colorectal cancer
Phase 1 CEA-PRIT 2.0 pretargeted alpha therapy targeting CEACAM5 (CEA)
This first-in-human, open-label Phase 1 study from Roche/Genentech evaluates CEA-PRIT 2.0, a multi-step “pretargeted” radioimmunotherapy designed to deliver the alpha-emitter lead-212 to CEACAM5 (CEA)–expressing…
NCT07416552 First-in-human - Trial result
Colorectal cancer
BXQ-350 (Saposin C nanovesicle; sphingolipid “homeostasis” modulator) + mFOLFOX7/bevacizumab posts 61% ORR in 1L mCRC
BXQ-350 is a Saposin C nanovesicle designed to allosterically activate sphingolipid metabolism—reported here to lower GM3/GluCer/S1P and raise ceramides—combined with first-line mFOLFOX7 plus bevacizumab in a Phase…
NCT05322590 - Trial result
Colorectal cancer
Perioperative propranolol (β-blocker) + etodolac (COX-2 inhibitor) shows manageable bradycardia and exploratory DFS signal in CRC
Perioperative propranolol (non-selective β-adrenergic blocker; slow-release, titrated from 20mg BID pre-op to 80mg BID on surgery day) plus etodolac (semi-selective COX-2 inhibitor; 400mg BID) was evaluated across…
NCT00502684 - New trial Spotlight
Colorectal cancer
Phase 3 precemtabart tocentecan (CEACAM5 ADC delivering TOP1 inhibitor exatecan) in previously treated mCRC
This randomized, open-label, 3-arm Phase 3 study (PROCEADE-CRC-03) tests whether precemtabart tocentecan (Precem‑TcT; also known as M9140)—a CEACAM5-targeted antibody–drug conjugate that delivers the topoisomerase 1…
NCT07549412 Registrational - New trial
Colorectal cancer
Phase 2 balstilimab PD-1 mAb + botensilimab Fc‑enhanced CTLA‑4 mAb + agenT‑797 allo‑iNKT therapy
This Phase 2, open-label, single-arm study tests whether adding cellular therapy to dual checkpoint blockade can generate responses in proficient MMR (MSS/pMMR) metastatic colorectal cancer with active liver…
NCT07550088 Exploratory - New trial
Colorectal cancer
Phase 1/2 pidnarulex (RNA Pol I inhibitor, G-quadruplex stabilizer) + cemiplimab (PD-1)
This NCI-sponsored Phase 1 dose-finding plus randomized Phase 2 study tests whether adding cemiplimab (Regeneron/Sanofi’s PD-1–blocking monoclonal antibody) can improve outcomes versus pidnarulex alone in refractory…
NCT07147231 Exploratory - Trial result
Colorectal cancer
NG-350A (CD40 agonist oncolytic adenoviral vector) + long-course CRT drives 80% near-cCR at W12 in pMMR LARC (FORTRESS Phase 1b)
NG-350A is an intravenously delivered, tumor-selective oncolytic adenoviral vector engineered to locally express an agonistic anti-CD40 antibody (immune-activating transgene), evaluated with standard long-course…
NCT06459869 - Trial result Spotlight
Colorectal cancer
ADG126 (masked anti-CTLA-4) + pembrolizumab + fruquintinib drives 25–50% PRs in 4L MSS CRC (early Ph1b)
ADG126 (muzastotug) is a protease-activated “masked” anti-CTLA-4 IgG1 designed for tumor-selective CTLA-4 engagement, here combined with pembrolizumab (PD-1) and fruquintinib (VEGFR1/2/3 TKI) in a Phase 1b 4th-line…
NCT05405595 - Trial result
Colorectal cancer
FOLFIRI–cetuximab (EGFR mAb) sequencing fails to beat bevacizumab strategy on disease control in RAS/BRAFV600E WT mCRC
STRATEGIC-1 (GERCOR-PRODIGE-39; Phase III, randomized, open-label; NCT01910610) enrolled untreated, unresectable RAS/BRAFV600E wild-type metastatic colorectal cancer (n=263) to compare Arm A (FOLFIRI+cetuximab →…
NCT01910610 - Trial result
Colorectal cancer
BXQ-350 (saposin C nanovesicle; sphingolipid “homeostasis” modulator) + mFOLFOX7/bevacizumab shows 61% ORR with low severe CIPN in 1L mCRC
BXQ-350 is a saposin C–containing nanovesicle designed to allosterically shift dysregulated sphingolipid metabolism (↓GM3/GluCer/S1P; ↑ceramides) and was combined with first-line mFOLFOX7 + bevacizumab in a Phase…
NCT05322590 - Trial result
Colorectal cancer
BI 905711 (TRAILR2/CDH17 bispecific) shows biomarker apoptosis but only stable disease in refractory GI cancers
BI 905711 is a TRAILR2/CDH17 bispecific antibody designed to trigger extrinsic apoptosis signaling in CDH17+ GI tumors; in Phase I monotherapy dose escalation/expansion (NCT04137289) in advanced refractory GI cancers…
NCT04137289 - Trial result
Colorectal cancer
Botensilimab (Fc-enhanced anti-CTLA-4) + balstilimab (anti–PD-1) posts 71% iRECIST DCR in chemo-free 1L “liver-sparing” MSS mCRC
BOT is a 2nd-gen Fc-modified anti-CTLA-4 designed to enhance Treg depletion and myeloid activation, and BAL is an anti–PD-1 antibody; they were tested in a Phase I/II first-line study in anatomically selected Stage…
NCT06268015 - New trial Spotlight
Colorectal cancer
Phase 1 BAY 3771249 KRAS G12D-selective inhibitor ± EGFR antibody cetuximab in mCRC
Bayer (with partner Kumquat Biosciences) is running an open-label Phase 1 master protocol testing BAY 3771249 (also referenced as KQB548), an oral small-molecule KRAS G12D-selective inhibitor, given alone or combined…
NCT07535112 Exploratory - Trial result
Colorectal cancer
FOLFOXIRI+Bevacizumab (VEGF) extends PFS vs doublets in unresectable liver-only/right-sided/RAS or BRAF-mut mCRC
FOLFOXIRI+bevacizumab (VEGF blockade) was tested as first-line therapy in an individual-patient pooled analysis of 4 randomized trials (TRIBE, TRIBE2, CHARTA, STEAM) focused on initially unresectable liver-only,…
- New trial
Colorectal cancer
Phase II fruquintinib (VEGFR) + FOLFIRI in second-line mCRC
SCRI adds selective VEGFR inhibition to Q2-week FOLFIRI. In 2L mCRC, FOLFIRI ± bevacizumab or anti-EGFR (for RAS/BRAF-WT left-sided) is typical; fruquintinib may extend VEGF blockade beyond bev to sustain disease…
NCT07011576 Exploratory - New trial Spotlight
Colorectal cancer
Phase 2 Fruquintinib (VEGFR inhibitor) and Tislelizumab (PD-1 mAb) in MRD-Positive Colorectal Cancer
This Phase 2 trial, sponsored by M.D. Anderson, investigates whether fruquintinib—a VEGFR inhibitor small molecule—and tislelizumab, a PD-1–targeting monoclonal antibody, can reduce recurrence in stage II–IV…
NCT07136077 Exploratory - New trial
Colorectal cancer
Phase Ib/II Regorafenib (multikinase inhibitor) plus Lorigerlimab (PD-1/CTLA-4 bispecific) Neoadjuvant Trial for lung-limited mCRC
This Phase Ib/II study from MD Anderson Cancer Center is evaluating neoadjuvant treatment in patients with resectable, lung-limited metastatic colorectal cancer harboring pMMR/MSS tumors. Patients receive oral…
NCT07137390 Exploratory - New trial
Colorectal cancer
Phase 1b Botensilimab (CTLA-4 mAb) & Balstilimab (PD-1 inhibitor) + SBRT in CRC
This pilot feasibility study by Massachusetts General Hospital evaluates a single‐arm combination treatment in chemorefractory, MSS (non-MSI-H/proficient mismatch repair) colorectal cancer with liver metastasis.…
NCT07128355 Exploratory - Trial result
Colorectal cancer
Panitumumab (EGFR) Maintenance: Spatial Immune Markers Predict Benefit in RAS-WT mCRC
Panitumumab, an anti-EGFR IgG2, was tested as FU/FA maintenance (±Pmab) after Pmab+FOLFOX induction in PanaMa; this translational analysis profiled 12 immune markers in tumor/stroma compartments from resections…
NCT01991873 - New trial
Colorectal cancer
Phase 2 NALIRIFOX trial: liposomal irinotecan (topoisomerase I inhibitor) for advanced small intestine/appendiceal cancers
This trial assesses the safety and efficacy of first-line chemotherapy in advanced disease. The study uses an expansion arm receiving investigational NALIRIFOX regimen with nal-IRI (liposomal topoisomerase I…
NCT07060014 Exploratory - New trial
Colorectal cancer
Phase II Pembrolizumab PD-1 inhibitor plus Odetiglucan immune activator combination trial
Investigating safety and efficacy, Abramson Cancer Center at Penn Medicine is evaluating the combination of pembrolizumab—a PD-1 blocking monoclonal antibody—and odetiglucan, a glucan-based immune activator, in…
NCT07082439 Exploratory - Trial result
Colorectal cancer
Lonsurf (TAS‑102) Nudges ctDNA Clearance to 36% and Extends DFS to 9.4 mo in MRD‑Positive CRC
Lonsurf (TAS‑102; trifluridine / tipiracil, a thymidine‑based nucleoside analog plus thymidine‑phosphorylase inhibitor), previously approved for mCRC, was given for six 28‑day cycles in the single‑arm, phase II…
NCT05343013 - New trial
Colorectal cancer
Phase 1b Regorafenib and Lorigerlimab in Colorectal Cancer: Multi-kinase inhibitor and bispecific antibody.
This trial by MD Anderson evaluates the combination of regorafenib, a multiple kinase inhibitor, and lorigerlimab, a CD279 and CTLA4-directed bispecific monoclonal antibody, administered for up to 6 months in…
NCT07071961 Exploratory - Trial result
Colorectal cancer
Biweekly capecitabine + oxaliplatin (CAPOX) slashes cytopenias while matching 3‑yr DFS in high‑risk stage II/III colorectal cancer
CAPOX couples oral fluoropyrimidine (capecitabine) with platinum DNA‑crosslinking agent oxaliplatin; the standard adjuvant schedule is every 3 weeks. In the Chinese phase II RCT NCT03564912, 160 post‑surgery…
NCT03564912
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