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Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer

NCT02751918CompletedPHASE1INTERVENTIONAL

Summary

Anetumab ravtansine is developed for the treatment of patients with recurrent platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated liposomal doxorubicin in this indication.

Key Facts

Lead Sponsor

Bayer

Enrollment

Start Date

2016-06-08

Completion Date

2019-08-23

Study Type

INTERVENTIONAL

Official Title

An Open-label Phase Ib Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Maximum Tolerated Dose of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin 30 mg/m2 Given Every 3 Weeks in Subjects With Mesothelin-expressing Platinum-resistant Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Interventions

Anetumab ravtansine (BAY94-9343)Pegylated Liposomal Doxorubicin

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Subjects with locally invasive or metastatic, epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Subjects must provide samples of tumor tissue
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Subjects with low-grade ovarian, fallopian tube, or Primary peritoneal cancer
* Women who are pregnant or breast feeding
* Subjects who have an active hepatitis B virus or hepatitis C virus infection requiring treatment as defined in the protocol

Outcome Measures

Primary Outcomes

Maximum tolerated dose (MTD) of Anetumab ravtansine in combination with pegylated liposomal doxorubicin when given every three weeks

MTD is defined as the highest dose of anetumab ravtansine administered in combination with pegylated liposomal doxorubicin that can be given such that not more than 1 of 6 subjects at a given dose level experiences a dose-limiting toxicity (DLT).

Time frame: Up to 6 months, minimum: 1 cycle (=21days)

Incidence of serious and non-serious adverse events (AEs)

Time frame: Up to 6 months

Secondary Outcomes

AUC (area under the plasma concentration vs. time curve from zero to infinity after single (first) dose) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)

Time frame: At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1

AUC(0-tlast) (AUC from time zero to the last data point > lower limit of quantification) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)

Time frame: At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1

Cmax (maximum drug concentration in plasma after first dose administration) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)

Time frame: At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1

AUC of total pegylated liposomal doxorubicin

Time frame: At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1

AUC(0-tlast) of total pegylated liposomal doxorubicin

Time frame: At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1

Cmax of total pegylated liposomal doxorubicin

Time frame: At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose, beginning on day 1 of cycle 1

Incidence of patients with CR, PR, SD or PD according to RECIST 1.1

CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease)

Time frame: Up to 17 months or until discontinuation of study, whichever comes first

Incidence of positive anti-drug antibody titer

Time frame: Up to 17 months or until discontinuation of study, whichever comes first

Incidence of positive neutralizing antibody titer

Time frame: Up to 17 months or until discontinuation of study, whichever comes first

Locations

Rocky Mountain Cancer Centers, Aurora, United States

Yale University School of Medicine, New Haven, United States

Oklahoma University Health Science Center, Oklahoma City, United States

UZ Leuven Gasthuisberg, Leuven, Belgium

The Institute of Oncology, Chisinau, Moldova

Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona, Spain

Clinica Universidad de Navarra CUN en Madrid, Madrid, Spain

Clínica Universidad de Navarra CUN, Pamplona, Spain

Instituto Valenciano de Oncología, Valencia, Spain

Linked Papers

2023-04-03

Safety and activity of anti-mesothelin antibody–drug conjugate anetumab ravtansine in combination with pegylated-liposomal doxorubicin in platinum-resistant ovarian cancer: multicenter, phase Ib dose escalation and expansion study

Anetumab ravtansine is an antibody-drug conjugate consisting of a fully human anti-mesothelin monoclonal antibody conjugated to cytotoxic maytansinoid tubulin inhibitor DM4. Mesothelin is highly expressed in ovarian cancer. This phase Ib study determines the safety, pharmacokinetics, and anti-tumor activity of anetumab ravtansine and pegylated liposomal doxorubicin in mesothelin-expressing platinum-resistant ovarian cancer. Anetumab ravtansine (5.5 or 6.5 mg/kg) and pegylated liposomal doxorubicin (30 mg/m In dose escalation, nine patients received anetumab ravtansine across two doses (5.5 or 6.5 mg/kg). The maximum tolerated dose of anetumab ravtansine was 6.5 mg/kg every 3 weeks and no dose-limiting toxicities were observed. In dose expansion, 56 patients were treated at the maximum tolerated dose. The most common treatment-emergent adverse events of any grade were nausea (47.7%), decreased appetite (43.1%), fatigue (38.5%), diarrhea (32.3%), and corneal disorder (29.2%). In all treated patients the objective response rate was 27.7% (95% CI 17.3% to 40.2%), including one complete (1.5%) and 17 partial responses (26.2%), with median duration of response of 7.6 (95% CI 3.3 to 10.2) months and median progression-free survival of 5.0 (95% CI 3.2 to 6.0) months. In an exploratory analysis of a sub-set of patients (n=19) with high mesothelin expression who received ≤3 prior lines of systemic therapy, the objective response rate was 42.1% (95% CI 20.3% to 66.5%) with a median duration of response of 8.3 (95% CI 4.1 to 12.0) months and median progression-free survival of 8.5 (95% CI 4.0 to 11.4) months. Anetumab ravtansine and pegylated liposomal doxorubicin showed tolerability and promising clinical activity. These results established the dose schedule and the mesothelin-positive target population of this combination for a phase III study in platinum-resistant ovarian cancer. NCT02751918.

Linked Investigators

Ana Oaknin

Dr. Ana Oaknin is the Head of the Gynaecological Cancer Programme at the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain and a prominent figure in the field of Gynaecological Oncology, internationally. Dr. Oaknin is an active faculty member of the European Society of Medical Oncology (ESMO) Gynaecologic Track. She has served as Scientific Commit Member for ESMO Meeting in the last few years, as Subject Editor for Gynaecologic Malignancies Guidelines (2022-2024)and she is chair of the ESMO gynaecological cancer congress (2024-2026). Dr. Oaknin has been the Gynaecologic Cancer Intergroup (GCIG) Cervical Cancer Committee Chair from 2022-2224 and is an active member of American Society of Clinical Oncology (ASCO), Society of Gynaecologic Oncology (SGO) where she serves as International Member on the Board Committee. Dr. Oaknin obtained her degree in Medicine and Surgery from the Complutense University of Madrid in 1994 and specialized in Medical Oncology at the Hospital Universitario de la Princesa, Universidad Complutense de Madrid, becoming board certified in 2000. She earned her PhD Cum Laude from the Universidad Autónoma de Barcelona in 2016. Throughout her career, Dr Oaknin has been primarily focused on clinical research, serving as the principal investigator for numerous Phase I, II, and III studies, both nationally and internationally. She is the author of many outstanding articles in high impact journals.

Bradley J. Monk

Robert L. Coleman