18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) CriteriaPrimary· Up to disease progression or end of study (up to 1 year and 9 months)
ORR was defined as the percentage of participants with a best overall response (BOR) of partial or complete response (PR or CR). BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
6.7
1.2 – 19.5
Cohort 2: Debio 1347 (Urothelial Cancer)
0
0.0 – 63.2
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
4.0
0.2 – 17.6
Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC)Secondary· Up to disease progression or end of study (up to 2 years and 9 months)
DOR was defined as the time from the date of the initial PR or CR to date of the first documented progression or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
5.55
NA – NA
Disease Control Rate (DCR) as Centrally Measured by Independent Review Committee (IRC)Secondary· Up to disease progression or end of study (up to 2 years and 9 months)
DCR was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or stable disease (SD) ≥6 weeks. BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
63.3
43.9 – 80.1
Cohort 2: Debio 1347 (Urothelial Cancer)
0
0 – 60.2
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
34.5
17.9 – 54.3
Progression-Free Survival (PFS) as Centrally Measured by Independent Review Committee (IRC)Secondary· From the start of the study up to disease progression or death (up to 2 years and 9 months)
PFS was defined as the time from the start date of treatment to date of the first documented progression or death due to any cause.
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
3.68
3.55 – 10.58
Cohort 2: Debio 1347 (Urothelial Cancer)
1.77
0.95 – NA
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
1.84
1.71 – 3.52
Overall Survival (OS)Secondary· Until death or loss to follow-up or end of study (up to 2 years and 9 months)
OS was defined as the time from the start date of treatment to date of death due to any cause. Participants with no documented death were censored at the last date known to be alive.
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
NA
NA – NA
Cohort 2: Debio 1347 (Urothelial Cancer)
NA
NA – NA
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
7.13
4.30 – 11.37
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Assessed by National Cancer Institute Common Terminology Criteria (NCI CTCAE) v5.0 and Serious Adverse Events (SAEs)Secondary· From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months)
An AE is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that either starts or worsens in severity on or after the first administration of the study drug and within 30 days of the last administration of the study drug. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or signific
TEAEs
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
30
Cohort 2: Debio 1347 (Urothelial Cancer)
4
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
28
Serious TEAEs
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
14
Cohort 2: Debio 1347 (Urothelial Cancer)
2
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
7
Trough Concentration at Steady State (Ctrough,ss) of Debio 1347 in PlasmaSecondary· Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
Geometric mean and geometric percent CV summary was estimated based on log-linear model.
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
619.6
± 100.0
Cohort 2: Debio 1347 (Urothelial Cancer)
306.8
± 43.4
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
463.2
± 127.3
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Debio 1347 in PlasmaSecondary· Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
Geometric mean and geometric percent CV summary was estimated based on log-linear model.
Group
Value
95% CI
Cohort 1: Debio 1347 (Biliary Tract Cancer)
23326.7
± 70.4
Cohort 2: Debio 1347 (Urothelial Cancer)
13999.0
± 39.1
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
18192.1
± 86.2
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to 30 days post last dose (up to 2 years and 9 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1: Debio 1347 (Biliary Tract Cancer)
Serious: 14/30 (47%)
Deaths: 9/30
Cohort 2: Debio 1347 (Urothelial Cancer)
Serious: 2/4 (50%)
Deaths: 1/4
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
Serious: 7/29 (24%)
Deaths: 17/29
Serious adverse events (31 terms)
Reaction
System
Cohort 1: Debio 1347 (Bili…
Cohort 2: Debio 1347 (Urot…
Cohort 3: Debio 1347 (All …
Acute kidney injury
Renal and urinary disorders
—
—
—
Pyrexia
General disorders
—
—
—
Biliary sepsis
Infections and infestations
—
—
—
Biliary tract infection
Infections and infestations
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03344536 — A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer
· Phase 1, PHASE2
· completed
Other recruiting trials for Solid Tumor
Currently open trials in the same condition.
NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar
· recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
· EARLY_PHASE1
· recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss
· Phase 1
· recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET
· active not recruiting
Other Debiopharm International SA trials
Trials by the same sponsor.
NCT05147350 — Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
· Phase 1
· terminated
NCT05364944 — A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Ac
· Phase 1
· terminated
NCT05147272 — Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
· Phase 1
· terminated
NCT04962724 — A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male
· Phase 1
· completed
NCT03968653 — Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors
· Phase 1
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Debiopharm International SA
Last refreshed: 7 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03834220.