A Phase 1 interventional study of Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles and Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles in Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma and Solid Tumor, sponsored by Tyra Biosciences, Inc. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Tyra Biosciences, Inc · Phase 1, Interventional, and Treatment
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Among 327 studies in Cholangiocarcinoma with a site in United States — 71 open to participants now, 110 under way, 7 of them phase 3. Cholangiocarcinoma · United States.
Among the 327 studies in Cholangiocarcinoma with a site in United States, this one is the 145th largest by planned enrollment of the 278 interventional ones that give a count, is one of 21 that started in 2023, is one of 85 in phase 1, reaches primary completion later than 34 of the 109 other live ones, and was the 267th registered.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
Browse Cholangiocarcinoma studies →71 of the 327 studies in Cholangiocarcinoma with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 18+
University of Wisconsin, Madison · Sites in United States
Ages 18+
University of Washington · Sites in United States
Ages 18+
Full-Life Technologies UK Limited · Sites in United States, Australia
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 211 Cholangiocarcinoma studies recruiting now, 141 (67%) set no upper age limit and 49 (23%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
327 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 127 · Phase 2 141 · Phase 3 24 · Phase 4 1
First in 2001; this study’s year is marked. 21 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 50 across 623 interventional studies indexed under Cholangiocarcinoma.
Median enrollment 44 across the 278 interventional studies, 230 across the 45 observational. Of the 190 that completed or were terminated, 94 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
134 of 327 have an industry lead sponsor. The 10 most frequent:
Tyra Biosciences, Inc is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Tyra Biosciences, Inc has 1 study filed under Cholangiocarcinoma — fewer than ten, so there is no comparison to draw.
36 of the studies in Cholangiocarcinoma with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05948475Phase 3TransThera Sciences (Nanjing), Inc.Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma | 2026-12 |
| NCT06506955Phase 3Taiho Oncology, Inc.Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. | 2027-04 |
| NCT05506943Phase 3Compass TherapeuticsA Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) | 2027-08-31 |
| NCT07265674Phase 3J-Pharma Co., Ltd.A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer | 2027-10 |
| NCT06723236MacroGenicsA Study of MGC028 in Participants With Advanced Solid Tumors | 2026-11 |
Add all 36 to your calendar (.ics) → With an account.
Among the 327 studies in Cholangiocarcinoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-200 in cancers with FGFR2 activating gene alterations, including unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors.
This is a single arm, multi-part, phase 1 clinical trial studying TYRA-200, a novel, potent fibroblast growth factor receptor (FGFR) 1/2/3 tyrosine kinase inhibitor, in unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2. Part A is a dose escalation study in participants with any advanced solid tumor with FGFR/FGF pathway alterations who have exhausted approved standard therapies. Part A will evaluate the safety, tolerability, and PK of TYRA-200 to determine the optimal and maximum tolerated dose (MTD). Part B will evaluate the preliminary antitumor activity of TYRA-200 in participants with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma who have previously received an FGFR inhibitor and have FGFR2 kinase-domain mutations resistant to other FGFR inhibitors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1 Part A
Phase 1 Part B
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TYRA-200 taken once daily by mouth in 28-day cycles
Drug: Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles · Drug: Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.
TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.
Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200.
Time frame: Initiation of study treatment through 28 Days
Phase 1 Part B: To determine the optimal dose of TYRA-200.
Time frame: Initiation of study treatment through 28 days (up to approximately 18 months
Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability.
Time frame: From day 1 treatment through 28-days post treatment (up to 2 years)
Frequency in changes in laboratory parameters and physical signs of toxicity.
Time frame: From day 1 treatment through 28-days post treatment (up to 2 years)
Pharmacokinetics: maximum plasma concentration (Cmax).
Time frame: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: time to reach maximum plasma concentration (Tmax).
Time frame: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: area under the plasma concentration-time curve (AUC).
Time frame: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: half-life of Tyra-200 (t1/2).
Time frame: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Overall response rate (ORR) defined as the proportion of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST V1.1.
Time frame: From enrollment, every 8 or 12 weeks (up to 2 years)
Duration of response defined as the time from the initial CR or PR to the time of relapse or death, whichever occurs first among participant with an objective response.
Time frame: From enrollment, every 8 or 12 weeks (up to 5 years)
Disease control rate defined as the proportion of participants having a CR, PR or stable disease (SD) for >12 weeks.
Time frame: From enrollment up to 5 years
Time to response defined as time to first CR or PR that is subsequently confirmed according to RECIST v1.1.
Time frame: Up to 5 years
Progression-free survival defined as the time from the date of first study drug administration to the earliest date of documented disease progression or death.
Time frame: From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (up to 5 years)
Started Nov 2023 (actual). Primary completion is estimated for Mar 2027, 40 months after the start.
Of 44 industry-sponsored phase 1 interventional studies under Cholangiocarcinoma, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 60. This study's planned 40 months is close to that.
Counting every sponsor, half of 67 studies reached it within 46 months; a quarter within 30 and three quarters within 63.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Mar 2027, on Oct 14, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Tyra Biosciences, Inc