Clinical trial · Interventional

Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC

A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

NCT06592664CI-TRIAL-00090689FORTIFIDEwithdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Management Decision

Summary

Brief summary (as posted)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma. The main questions it aims to answer are: * is the new drug plus standard treatment safe and tolerable * is the new drug plus standard treatment more effective than standard treatment Participants will: * Visit the clinic three times every 28 days for treatment and tests * Have CT or MRI scans every 8 weeks while on treatment

Conditions

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastatic Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_BROADER	0.78
Pancreas Adenocarcinoma	Pancreatic Adenocarcinoma	ALIAS	0.90
Pancreas Cancer	Pancreatic Carcinoma	ALIAS	0.90
Pancreatic Carcinoma	Pancreatic Carcinoma	ONTOLOGY_EXACT	0.98
Pancreatic Ductal Adenocarcinoma	Pancreatic Ductal Adenocarcinoma	ONTOLOGY_EXACT	0.98
PDAC	Pancreatic Ductal Adenocarcinoma	ALIAS	0.90
PDAC - Pancreatic Ductal Adenocarcinoma	Pancreatic Neoplasm	PROBABILISTIC	0.70

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
certepetide	Drug	—	UNRESOLVED
gemcitabine	Drug	Gemcitabine	ALIAS
nab-paclitaxel	Drug	Nab-paclitaxel	ALIAS
placebo matching certepetide	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion
interventionNames
1. Drug: certepetide
2. Drug: nab-paclitaxel
3. Drug: gemcitabine
4. Drug: placebo matching certepetide
type
EXPERIMENTAL
label
SoC chemotherapy plus two certepetide IV pushes and placebo infusion
interventionNames
1. Drug: nab-paclitaxel
2. Drug: gemcitabine
3. Drug: certepetide
4. Drug: placebo matching certepetide
type
ACTIVE_COMPARATOR
label
SoC chemotherapy plus two placebo IV pushes and placebo infusion
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been treated previously and be eligible for treatment with nab-paclitaxel and gemcitabine
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy ≥ 3 months
* At least one measurable tumor lesion as assessed by RECIST 1.1
* Adequate organ and marrow function
* Adequate contraception

Exclusion Criteria:

* Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or biological agents
* Received prior anti-cancer therapy for their pancreatic cancer
* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results, including but not limited to:

  * Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment
  * Active infection (viral, fungal, or bacterial) requiring systemic therapy
  * Known active hepatitis B virus, hepatitis C virus, or HIV infection
  * Active tuberculosis as defined per local guidance
  * History of allogeneic tissue/solid organ transplant
  * Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
  * Pregnant or breastfeeding
  * Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization
* History or clinical evidence of symptomatic central nervous system (CNS) metastases
* Enrolled in any other clinical protocol or investigational trial

References

Publications (0)

Data not yet available

No reference posted for this study.