Japanese Phase 1 Trial of Sym004 in Solid Tumors

A Japanese Phase I Open-label Dose-escalation Trial of Sym004 Administered as Monotherapy in Japanese Subjects With Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222258

Enrollment

Registered

2013-10-21

Start date

2013-10-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Interventions

investigational material(s) Generic name etc : Sym004 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Japanese male or female subjects aged greater than or equal to 20 years at the time of informed (2)consent signature (3)Histologically or cytologically confirmed cancer (4)Refractory or recurrent advanced late stage solid tumors without available therapeutic options which are likely to provide patient benefit (failure and/or intolerance to standard anti-cancer therapy) (5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (6)Life expectancy of at least 3 months (7)Written informed consent given before any trial-related activities are carried out

Exclusion criteria

Exclusion criteria: (1)Subjects with symptomatic brain metastases (2)Subjects who received total resection or irradiation of the target lesion (3)Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy, antibody therapy, tyrosine kinase inhibitors, and any investigational agent (4)Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004 at Week 1 (5)Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03) (6)Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03) (7)Magnesium of less than 0.9 milligram per deciliter (mg/dL) (8)Abnormal organ or bone marrow function as defined in the protocol (9)Received immunosuppressive agents (including systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent) within 4 weeks before the first administration of Sym004 at Week 1 (10)Active severe infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the Investigator (11)Known human immunodeficiency virus (HIV) positive, active Hepatitis B or C, or uncontrolled allergic conditions or allergy to Sym004 or its components (12)Clinically significant cardiac disease or concurrent, uncontrolled medical condition (13)Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies (14)Other protocol defined exclusion criteria could apply

Design outcomes

Primary

Measure	Time frame
safety (1)Dose Limiting Toxicity [ Time Frame: Up to Week 4 ] [ Designated as safety issue: Yes ] (2)Number of subjects with Adverse Events [ Time Frame: Up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: Yes ]	—

Secondary

Measure	Time frame
efficacy pharmacokinetics pharmacodynamics (1)Pharmacokinetic profile of Sym004: Area under curve (AUC), Half-life (t1/2 ), Clearance (CL), Volume of distribution at the elimination phase (Vz ), Maximum concentration (Cmax ), Trough concentration (Ctrough), Time to reach Cmax (tmax ) [ Time Frame: Up to 8 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (2)Best overall response rate [ Time Frame: Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (3)Duration of overall response [ Time Frame: Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (4)Disease control rate [ Time Frame: Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (5)Duration of disease control [ Time Frame: Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (6)Time to progression [ Time Frame: Time from enrollment until the date of objectively documented disease progression, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (7)Progression-free survival time [ Time Frame: Time from enrollment until the date of objectively documented disease progression or death, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (8)Change from Baseline in anti-drug antibody (ADA) titer at Weeks 1 and 5 [ Time Frame: Baseline, Weeks 1 and 5 ] [ Designated as safety issue: No ] (9)Epidermal growth factor receptor levels in skin tissues [ Time Frame: Weeks 1 and 5 ] [ Designated as safety issue: No ]	—

Measure

Time frame

efficacy pharmacokinetics pharmacodynamics (1)Pharmacokinetic profile of Sym004: Area under curve (AUC), Half-life (t1/2 ), Clearance (CL), Volume of distribution at the elimination phase (Vz ), Maximum concentration (Cmax ), Trough concentration (Ctrough), Time to reach Cmax (tmax ) [ Time Frame: Up to 8 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (2)Best overall response rate [ Time Frame: Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (3)Duration of overall response [ Time Frame: Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (4)Disease control rate [ Time Frame: Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (5)Duration of disease control [ Time Frame: Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (6)Time to progression [ Time Frame: Time from enrollment until the date of objectively documented disease progression, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (7)Progression-free survival time [ Time Frame: Time from enrollment until the date of objectively documented disease progression or death, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ] (8)Change from Baseline in anti-drug antibody (ADA) titer at Weeks 1 and 5 [ Time Frame: Baseline, Weeks 1 and 5 ] [ Designated as safety issue: No ] (9)Epidermal growth factor receptor levels in skin tissues [ Time Frame: Weeks 1 and 5 ] [ Designated as safety issue: No ]

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026