Health TrialsbyHealthPanel

A Study of PHN-012 in Patients With Advanced Solid Tumors

ConditionsColon CancerPancreatic CancerLung Cancer (NSCLC)Advanced CancerAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPheon Therapeutics

About this trial

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Colorectal adenocarcinoma (CRC), or

Non-small cell lung cancer (NSCLC), or

Pancreatic ductal adenocarcinoma (PDAC).

Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.

Disqualifiers

Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.

Has unstable central nervous system metastasis.

Has persistent toxicities from previous systemic anti-cancer treatments of Grade >1.

Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.

Trial design

Design model

Sequential

Treatments tested in this trial

  • PHN-012

    Drug

    PHN-012 is an ADC

Treatment groups

165 Participants
are divided into 1 treatment group
Group A: Phase 1a and Phase 1bExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (Phase 1a)

Time frame
12 months
2

Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)

Time frame
12 months
3

Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)

Time frame
24 months
4

Overall response rate (ORR) (Phase 1b)

Time frame
12 months

Secondary outcomes

1

Best overall response (BOR) (Phase 1a and 1b)

Time frame
24 months
2

Disease control rate (DCR) (Phase 1a and 1b)

Time frame
24 months
3

Progression free survival (PFS) (Phase 1a and 1b)

Time frame
24 months
4

Time to response (TTR) (Phase 1a and 1b)

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Pheon Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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