Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Recurrence

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Carcinoma, Ovarian Epithelial

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenoma

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Lung Diseases

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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

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Malignant Mesothelioma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks

3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 2); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 2i)

3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 3); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 3i)

3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 4); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 4i)

MCY-M11

Intravenous administration for preconditioning

Claudio Dansky Ullmann, MD

This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.

Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma

A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women With Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects With Peritoneal Mesothelioma With Recurrence After Prior Chemotherapy

number and severity of adverse events according to NCI CTCAE v.5.0

tumor response scored by irRECIST criteria

CTI Clinical Trial and Consulting Services

MaxCyte, Inc.

Dianhydrogalactitol

VAL-083 given by intravenous infusion with a starting dose of 60 mg/m2 once weekly. If this regimen is well tolerated for at least three sequential weekly treatments the patient's dose may be escalated to 67 mg/m2 i.v. If the 67 mg/m2 dose is well tolerated for at least three sequential weekly treatments the patient's dose may be escalated to 75 mg/m2 i.v. once weekly for the remainder of the study. Dosing will be conducted once per week for a total of 16 weeks.

VAL-083, Dianhydrogalactitol

Bradley J Monk, M.D.

This is an open label, multi-center, Phase 1/2 clinical trial in subjects with recurrent adenocarcinoma of the ovary who have been previously treated with a minimum of two courses of platinum-based chemotherapy, and up to two additional cytotoxic regimens that may also have included platinum (no more than four total lines of prior therapy), with or without bevacizumab, whose cancer has recurred within six months of the most recent platinum-based chemotherapy. All eligible subjects will receive VAL 083 i.v. in a once weekly cycle until disease progression, development of other unacceptable toxicity, death, withdrawal of consent, loss to follow-up, or Sponsor ending the study, whichever occurs first.

The basis of drug treatment for advanced-stage ovarian cancer in the first-line setting is platinum (cisplatin or carboplatin) plus taxane (paclitaxel or docetaxel), with or without bevacizumab. First line treatment regimens often result in high response rates, but most tumors will recur within 2 years and patients die within 3 to 4 years of diagnosis. If a patient progresses after 2 consecutive regimens without a response (refractory) or has recurrent ovarian cancer within 6 months from their last platinum-based regimen (platinum-resistant), prognosis is poor. The absence of an approved treatment or standard of care in the recurrent setting represents an unmet need.

Early NCI studies in the 1970s and 1980s support VAL-083 activity in ovarian cancer. Interest in this agent for ovarian cancer has recently re-emerged. The unique functional groups and cytotoxic mechanisms are hoped to provide a viable novel treatment option in patients with recurrent ovarian cancer that was resistant to platinum chemotherapies.

This is an open label, multi-center, Phase 1/2 clinical trial in subjects with recurrent adenocarcinoma of the ovary who have been previously treated with a minimum of two courses of platinum-based chemotherapy, and up to two additional cytotoxic regimens that may also have included platinum (no more than four total lines of prior therapy), with or without bevacizumab, whose cancer has recurred within six months of the most recent platinum-based chemotherapy.

Study subjects will initially receive VAL-083 60 mg/m2 i.v. once weekly. If this regimen is well tolerated for at least three sequential weekly treatments, the patient's dose may be escalated to 67 mg/m2 i.v. If the 67 mg/m2 dose is well tolerated for at least three sequential weekly treatments, the patient's dose may be escalated to 75 mg/m2 i.v. once weekly for the remainder of the study. Dosing will continue once weekly for 16 weeks or until disease progression, development of other unacceptable toxicity, death, withdrawal of consent, loss to follow-up, or Sponsor ending the study, whichever occurs first. The treatment plan is to enroll a minimum number of 20 subjects in Phase 1, followed by expansion of enrollment in Phase 2 using the optimal dosing regimen determined in Phase 1.

Hematological safety assessments will be conducted at Screening and weekly before each treatment. Clinical evaluations for physical examination, vital signs, disease symptoms, quality of life measures (FOSI and opioid pain medication use), adverse events and concomitant medications will be completed while the subject remains on study treatment. Radiographic assessments (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) to obtain tumor measurements and CA-125 concentration will be conducted at Screening and every 8 weeks while on study treatment, independent of dose delays and/or dose interruptions, until progression of disease is suspected.

Pharmacokinetics will be evaluated in each of the first 10 subjects who have plasma samples drawn on Day 1 of study treatment: pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of i.v. infusion with VAL-083.

A post-treatment safety assessment is to be scheduled 28 ±7 days after the last dose of study treatment.

Follow-up for subjects terminating from study for any reason other than withdrawal of consent will be done to allow an exploratory assessment of survival. All anti-tumor treatments received after discontinuing treatment with VAL-083 will be collected, if available, and survival status will also be reported to the Sponsor, on a monthly basis, when survival data are available. In addition to survival, this assessment includes outcomes for subsequent anticancer therapies including any new malignancy information. Date and cause of death will be recorded.

The primary reason for study completion and discontinuation from monthly follow-up will be captured for each study subject.

A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer

A Phase 1/2, Open Label, Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer

The Clinical Study Report for this trial will be prepared and provided to the U.S. FDA as required by applicable regulatory requirement(s). Each participating trial investigator will be provided a copy of their patient data captured in the database for this trial.

Overall number of tumor complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or GCIG criteria using computed tomography (CT) or magnetic resonance imaging (MRI)

Using NCI CTCAE version 4 criteria to assess frequency, severity and study drug relationship of clinically significant changes in vital signs, lab test results, EKGs or any other adverse events reported while patients are receiving treatment with VAL-083

To measure the changes in concentration of CA-125 antigen levels in blood

Time from start of treatment until first occurrence of progression or patient death, whichever occurs first

Progression-free Survival for VAL-083 compared to Progression-free Survival for patient's last treatment regimen received

Time from start of treatment to achievement of either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or GCIG criteria using computed tomography (CT) or magnetic resonance imaging (MRI)

Length of time from start of treatment until patient death

Maximum observed plasma concentration of VAL-083 in the first 10 study subjects receiving VAL-083

Time of maximum observed plasma concentration of VAL-083 in the first 10 study subjects receiving VAL-083

Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration of VAL-083 in plasma for the first 10 study subjects receiving VAL-083

Area under the concentration-time curve extrapolated to infinity for VAL-083 in plasma of the first 10 study subjects receiving VAL-083

Terminal elimination rate constant determined by selection of at least 3 decreasing data points on the terminal phase of the concentration-time curve for VAL-083 in plasma of the first 10 study subjects receiving VAL-083

Terminal elimination half-life of VAL-083 in plasma of the first 10 study subjects receiving VAL-083

Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)

DelMar Pharmaceuticals, Inc.

Vaccines

Immunomodulating Agents

5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

2.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

0.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months

OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine

Henry E Schea

To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine.

To study the toxicity, safety and DTH response of DNP-modified autologous ovarian tumor cell vaccine and the DTH response to unmodified ovarian tumor cells in patients with relapsed ovarian cancer:

* To determine the tolerability and toxicity of the treatment regimen
* To determine whether O-Vax induces a DTH response to autologous, DNP-modified ovarian cancer cells
* To determine whether O-Vax induces a DTH response to autologous, unmodified ovarian cancer cells

Study Population: Patients with recurrent epithelial ovarian cancer whose therapeutic tumor surgery provides a mass which yields adequate tumor cells for vaccine preparation and delayed-type hypersensitivity (DTH) testing

Study Design: A Phase I/IIa double-blind, three-dose, multi-center study

Investigational Product: O-Vax: DNP-modified autologous ovarian tumor cell vaccine

Dosage Form: Cell suspension

Route of Administration: Intradermal

Dosage and Treatment Schedule: Prior to enrollment in the study, one dose of 5 x 106 modified and one dose of 5 x 106 unmodified autologous ovarian cancer cells will be administered, to establish a negative DTH response at baseline. Three dosing regimens will be used: 5 x 105, 2.5 x 106, or 5 x 106 DNP-modified autologous ovarian tumor cells. An initial dose of DNP-modified autologous ovarian tumor cells\* followed by cyclophosphamide then weekly doses of DNP-modified autologous ovarian tumor cells mixed with Bacillus of Calmette and Guérin (BCG) for 6 weeks, and completed with one dose of DNP-modified autologous ovarian tumor cells mixed with BCG as a 6 month booster if adequate cells

* count determined prior to aliquoting for cryopreservation

Endpoints: Treatment-emergent and related adverse events, serious adverse events, and Grade 3 and 4 laboratory abnormalities

Other Parameters:

* Delayed-type hypersensitivity skin reactions for assessing the induction of immune responses to DNP-modified and unmodified autologous ovarian tumor cells
* CA-125 levels
* Survival
* Exploratory analysis incorporating in vitro analysis of lymphocytes separated from patient blood samples

Duration of Treatment: Up to 6 months

Duration of Subject Participation in Study: Three months from the patient's last vaccine

Duration of Follow-up: Survival information will be collected via phone or visit on a quarterly basis for each patient beginning 30 days after the last scheduled visit

Number of Subjects Required to Meet Protocol Objectives: 42 evaluable subjects

Number of Study Centers: 4-5

Number of Individual Blood Draws: 13 draws over nine months

Volume of Blood Drawn: 11 Draws of 30 mL/draw (total 360 mL) and two draws of 50mL in heparinized tubes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma	NCT03608618	Peritoneal Meso... Fallopian Tube ... Adenocarcinoma ... Primary Periton...	MCY-M11 Cyclophosphamid...	18 Years -	MaxCyte, Inc.
A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer	NCT03281681	Ovarian Cancer	VAL-083, Dianhy...	18 Years -	Kintara Therapeutics, Inc.
A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer	NCT03281681	Ovarian Cancer	VAL-083, Dianhy...	18 Years -	Kintara Therapeutics, Inc.
A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer	NCT03281681	Ovarian Cancer	VAL-083, Dianhy...	18 Years -	Kintara Therapeutics, Inc.
A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer	NCT03281681	Ovarian Cancer	VAL-083, Dianhy...	18 Years -	Kintara Therapeutics, Inc.
Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian Cancer	NCT00660101	Adenocarcinoma ...	OVax: Autologou...	18 Years -	AVAX Technologies

Spots Global Cancer Trial Database for adenocarcinoma of the ovary