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Study of D3L-002 in Subjects With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorD3 Bio (Wuxi) Co., Ltd

About this trial

This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to provide written informed consent and comply with study procedures

Age ≥18 years

Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Disqualifiers

Prior anti-TIGIT or anti-PVRIG therapy

Recent anticancer therapy without adequate washout

Active or uncontrolled illness

Interstitial lung disease/pneumonitis

Trial design

Design model

Sequential

Treatments tested in this trial

  • D3L-002

    Drug

    D3L-002 is an investigational anti-TIGIT/anti-PVRIG bispecific antibody administered as an intravenous infusion every 3 weeks (Q3W).

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: D3L-002Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)

Incidence, nature, and severity of TEAEs and TRAEs assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

Time frame
From first dose through 30 days after the last dose (Safety Follow-up Visit)
2

Change from Baseline in Hemoglobin

Change from baseline in hemoglobin (g/dL)

Time frame
From baseline through 30 days after the last dose
3

Change from Baseline in White Blood Cell Count

Change from baseline in white blood cell count (×10\^9/L)

Time frame
From baseline through 30 days after the last dose
4

Change from Baseline in Platelet Count

Change from baseline in platelet count (×10\^9/L)

Time frame
From baseline through 30 days after the last dose

Secondary outcomes

1

Pharmacokinetics: Maximum Plasma Concentration (Cmax)

Maximum observed serum concentration of D3L-002 following intravenous administration

Time frame
From Day 1 through End of Treatment (up to approximately 6 months)
2

Pharmacokinetics: Minimum (Trough) Concentration (Ctrough)

Predose serum concentration of D3L-002 at steady state

Time frame
From Day 1 through End of Treatment (up to approximately 6 months)
3

Pharmacokinetics: Time to Maximum Concentration (Tmax)

Time from dosing to maximum observed serum concentration of D3L-002

Time frame
From Day 1 through End of Treatment (up to approximately 6 months)
4

Pharmacokinetics: Terminal Half-Life (t½)

Terminal elimination half-life of D3L-002 calculated from serum concentration-time data

Time frame
From Day 1 through End of Treatment (up to approximately 6 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

D3 Bio (Wuxi) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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