This study has been transitioned to CTIS with ID 2023-505455-44-00 check the CTIS register for the current data. Part 1 (phase 1b)Primary:• To observe the safety and tolerability of bemarituzumabSecondary:• To evaluate preliminary antitumor activity…
ID
Source
Brief title
Condition
- Other condition
- Benign neoplasms gastrointestinal
- Ovarian and fallopian tube disorders
Synonym
Health condition
basketstudie: meerdere indicaties, zie inclusie criteria
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1 (phase 1b)
• Dose-limiting toxicities (DLTs), treatment-emergent adverse events,
treatment-related adverse events, and clinically significant changes in vital
signs, visual acuity, and clinical laboratory tests
Part 2 (phase 2)
• OR
Secondary outcome
Part 1 (phase 1b)
• Objective response (OR) (OR = complete response [CR] + partial response
[PR]), measured by computed tomography (CT) or magnetic resonance imaging (MRI)
as determined by investigator per Response Evaluation Criteria in Solid Tumors
version 1.1 (RECIST v1.1)
• Disease control (DC) (CR, PR, or stable disease [SD])
• Duration of response (DOR), defined as the time from first documentation of
objective response (as determined by investigator per RECIST v1.1) until the
first documentation of disease progression or death due to any cause, whichever
occurs first. Only subjects who have achieved objective response will be
evaluated for DOR. Duration of response will be censored at the last evaluable
post-baseline tumor assessment prior to subsequent anticancer therapy.
• Time to response (TTR)
Part 2 (phase 2)
• OR
• DC
• DOR
• TTR
• PFS
• OS
• Treatment-emergent adverse events, treatment-related adverse events, and
clinically significant changes in vital signs, visual acuity, and clinical
laboratory tests
Background summary
Inhibition of FGFR2b signaling may be an effective mechanism of action for
multiple cancer indications and forms the basis for this study. Alterations in
the FGF/FGFR2 signaling pathway have been reported in the literature for
multiple tumor types. Data from The Cancer Genome Atlas (TCGA), report
detection of FGFR2 overexpression by mRNA is common amongst epithelial
cancers. Among high expressing cancers are cholangiocarcinoma (93.3%), ovarian
cancer (78.8%), pancreatic (33.9%), triple negative breast cancer (41.8%), head
and neck carcinoma (57.5%), esophageal squamous cell carcinoma (45.7%),
endometrial carcinoma (46.7%), cervical cancer (29.4%), and colorectal cancer
(12.9%). Evaluation of bemarituzumab in subjects with FGFR2b overexpressing
tumors may improve the outcome for these subjects by providing targeted
inhibition of tumor growth signaling.
Study objective
This study has been transitioned to CTIS with ID 2023-505455-44-00 check the CTIS register for the current data.
Part 1 (phase 1b)
Primary:
• To observe the safety and tolerability of bemarituzumab
Secondary:
• To evaluate preliminary antitumor activity
• Characterize the pharmacokinetics (PK) of bemarituzumab
Part 2 (phase 2)
Primary:
• To evaluate preliminary antitumor activity
Secondary:
• To evaluate other measures of preliminary antitumor activity
• To evaluate the safety and tolerability of bemarituzumab
• Characterize the PK of bemarituzumab monotherapy
Study design
This is a phase 1b/2, open-label, multicenter exploratory, basket study to
evaluate the efficacy and safety of bemarituzumab monotherapy in subjects
across multiple primary epithelial solid tumors with centrally determined
FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic
disease.
This study consists of a pre-screening period to collect tumor tissue for
centralized FGFR2b testing, a 28 day screening period, a treatment period, a
safety follow-up (SFU) period, and a long term follow up (LTFU) period.
Subjects who discontinue bemarituzumab will undergo a SFU visit 28 (+ 3) days
after the last dose of study treatment. In addition, subjects will undergo
LTFU for survival approximately every 3 months (± 1 month) after the SFU visit
for up to 2 years from the first dose of bemarituzumab. Subjects will receive
treatment until disease progression, unacceptable toxicity, subject request, or
death (whichever occurs first).
Intervention
Bemarituzumab will be administered as a short-term IV infusion every 14 days
(in a cycle of 14 days) as monotherapy.
Study burden and risks
Please refer to section E2 and E9.
Minervum 7061
Breda 4817 ZK
NL
Minervum 7061
Breda 4817 ZK
NL
Listed location countries
Age
Inclusion criteria
109 Histologically or cytologically confirmed cancer, advanced or metastatic,
refractory or relapsed after at least 1 prior standard treatment:
o Head and neck squamous cell carcinoma >= 1 line of therapy
o Triple-negative breast cancer >= 2 lines of therapy
o Intrahepatic cholangiocarcinoma >= 1 line of therapy
o Lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint
inhibitor, and targeted therapy (ie, if molecular testing has identified
targetable mutations in EGFR, ALK, etc)
o Ovarian epithelial carcinoma, including fallopian tube cancers and primary
peritoneal cancers, >= 1 line of therapy (platinum-resistant)
o Endometrial adenocarcinoma >= 1 line of therapy
o Cervical carcinoma >= 1 line of therapy
o Other solid tumours >= 1 line of therapy
104 Disease that is unresectable, locally advanced, or metastatic (not amenable
to curative therapy)
105 Tumor overexpresses FGFR2b as determined by centrally performed IHC testing
106 Measurable disease per RECIST v1.1
107 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
110 Adequate hematologic and organ function, defined as follows:
• Absolute neutrophil count >= 1.5 x 109/L
• Platelet count >= 100 x 109/L
• Hemoglobin >= 9 g/dL
• AST and ALT < 3 x upper limit of Normal [ULN] (or < 5 x ULN in case of liver
involvement). Total bilirubin < 1.5 x ULN (or < 2 x ULN in case of liver
involvement or Gilbert*s disease)
For more details please see section 5.1 Inclusion Criteria within the protocol.
Exclusion criteria
201 Untreated or symptomatic central nervous system (CNS) metastases or
leptomeningeal disease
• Subjects with asymptomatic CNS metastases are eligible if clinically stable
for at least 4 weeks and do not require intervention (including use of
corticosteroids)
• Subjects with treated brain metastases are eligible provided the following
criteria are met:
- Definitive therapy was completed at least 2 weeks prior to the first planned
dose of study treatment (stereotactic radiosurgery at least 7 days prior to
first planned dose of study treatment)
- At least 7 days prior to first planned dose of study treatment: any CNS
disease is clinically stable, subject is off steroids for CNS disease (unless
steroids are indicated for a reason unrelated to CNS disease), and subject is
off or on stable doses of anti-epileptic drugs
202 Other solid tumor cohort excludes primary tumors of the CNS, squamous non
small cell lung cancer, gastric adenocarcinoma, and gastroesophageal junction
adenocarcinoma
203 History of other malignancy within the past 2 years, with the following
exceptions:
• curatively treated non-melanoma skin malignancy
• cervical cancer in situ
• curatively treated uterine cancer stage I
• curatively treated ductal or lobular breast carcinoma in situ and not
currently receiving any systemic therapy
• localized prostate cancer that has been treated surgically with curative
intent and presumed cured
205 Active infection requiring systemic treatment or any uncontrolled infection
within 14 days prior to first dose of study treatment
For more details please see section 5.2 exclusion Criteria within the protocol.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-505455-44-00 |
| EudraCT | EUCTR2021-006386-38-NL |
| ClinicalTrials.gov | NCT-nummernognietbekend.Hetnummervolgt |
| CCMO | NL80395.000.22 |