A Study of ERY974 in Patient With Advanced Solid Tumors

Conditions

Solid Tumors

Brief summary

This is the open label, multicenter Phase 1 study which consists of a dose escalation to determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease progression.

Shunichiro Komatsu, Yoko Kayukawa, Yoko Miyazaki, Akihisa Kaneko, Hisashi Ikegami et al. (15 authors)

Scientific Reports2022-07-1910 citations

10.1038/s41598-022-16564-x

Abstract 5609: ERY974, a novel T cell-redirecting bispecific antibody targeting glypican-3, shows antitumor activity in gastric cancer patient-derived xenograft models with varying glypican-3 expression

Yumiko Azuma, Yuji Sano, Toshiaki Tsunenari, Yasuko Kinoshita, Yoko Miyazaki et al. (13 authors)

Cancer Research2018-07-012 citations

10.1158/1538-7445.am2018-5609

A phase 1 dose escalation (DE) and cohort expansion (CE) study of ERY974, an anti-Glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumors.

Yoshitaka Ogita, Daniel L. Weiß, Naofumi Sugaya, Mikiko Nakamura, Hajime Ito et al. (10 authors)

Journal of Clinical Oncology2018-05-2010 citations

10.1200/jco.2018.36.15_suppl.tps2599

Abstract 3653: Combining ERY974, a novel T cell-redirecting bispecific antibody targeting glypican-3, with chemotherapy profoundly improved antitumor efficacy over its monotherapy in xenograft model

Yuji Sano, Yumiko Azuma, Toshiaki Tsunenari, Yasuko Kinoshita, Yoko Kayukawa et al. (11 authors)

Cancer Research2017-07-012 citations

10.1158/1538-7445.am2017-3653

A phase I dose escalation (DE) and cohort expansion (CE) study of ERY974, an anti-glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumors.

Kenji Hashimoto, Ayesh D. Perera, Naofumi Sugaya, Yoshitaka Ogita, Mikiko Nakamura et al. (17 authors)

Journal of Clinical Oncology2017-05-204 citations

10.1200/jco.2017.35.15_suppl.tps3112

Interventions

DRUGERY974

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Male or female patient with Glypican 3 positive advanced solid tumor not amenable to standard therapy or for which standard therapy is not available or not indicated * Measurable tumor * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Adequate bone marrow, liver, and renal function * Adequate coagulation status

Exclusion criteria

* Patients with more than a single brain metastasis ( \>1 cm) * Patients with acute or chronic infection * Major surgery within 28 days * Pregnant or lactating women * Patients with interstitial pneumonitis * Patients require regular ascites/pleural effusion drainage

Design outcomes

Primary

Measure	Time frame	Description
Dose escalation： MTD determination	DLT evaluation period, defined as from the first ERY974 injection until 7 days after the third injection	Determination of dose-limiting toxicities (DLT)
Cohort expansion：Preliminary assessment of change in tumor size	From the date of informed consents obtained until disease progression: at screening , week 6,12,18 and subsequently every 3 months up to 38 months	Anti-tumor activity will be assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST)

Secondary

Measure	Time frame
Dose escalation： Number and severity of adverse events	Adverse events will be reported through 28 days after the last dose
Dose escalation： Plasma ERY974 concentrations	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Dose escalation：Area under curve (AUC)	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Dose escalation：terminal half-life	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Dose escalation：total clearance	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Dose escalation：volume distribution	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Dose escalation： Change in tumor size assessed by mRECIST	From the date of informed consents obtained until disease progression: at screening , week 6,12,18 and subsequently every 3 months up to 38 months
Dose escalation： Determining the recommended dose	Recommended dose will be determined after completion of DLT assessments in all dose escalation cohorts. It is estimated as 18 months after first patient enrollment.
Cohort expansion：Number and severity of adverse events	Adverse events will be reported through 28 days after the last dose
Cohort expansion ：Plasma ERY974 concentrations	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Cohort expansion ：Area under curve (AUC)	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Cohort expansion ：terminal half-life	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Cohort expansion ：total clearance	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months
Cohort expansion ：volume distribution	PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

Countries

France, Netherlands, United States

Outcome results

None listed