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Advanced Solid TumorPhase 1NCT05872867

Study of WM-A1-3389 in Participants With Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer (MK-3475-E90/KEYNOTE-E90)

A Phase 1 study testing WM-A1-3389 and Pembrolizumab in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Wellmarker Bio at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the present study is to determine the safety, tolerability, and efficacy of WM-A1-3389 in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
WM-A1-3389 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesSouth Korea
Study dates
14 Mar 2024to 22 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • [Stage 1: monotherapy]
  • Be ≥19 and <75 years of age
  • Participant with histologically and/or cytologically confirmed diagnosis of unresectable advanced or metastatic solid tumors that have been confirmed as progressed disease after standard of care or for which no further standard therapy is available due to intolerance or incompatibility
  • IGSF1 positive expression
  • Have measurable disease defined as at least one lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Have life expectancy ≥ 12 weeks
  • Have adequate organ functions defined as the following laboratory test criteria at screening (During the screening phase, one re-test will be permitted):
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin (Hb) ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 X Institutional Upper Limit of Normal (IULN) (Not applicable to patients with Gilbert syndrome)
  • Serum creatinine ≤ 1.5 X IULN
  • Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) ≤ 2.5 X IULN (AST and ALT ≤ 5 X IULN in patients with confirmed liver metastasis)
  • Prothrombin time (PT) ≤ 1.5 X IULN *IULN: Institutional Upper Limit of Normal
  • Have provided archival tumor tissue sample obtained within 3 months prior to IP administration or newly obtained biopsy
  • Have agreed to undergo up to 2 tumor tissue biopsies after IP administration
  • Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
  • [Stage 2: Combination therapy]
  • Be ≥ 19 and < 75 years of age
  • Participant with histologically and/or cytologically confirmed diagnosis of unresectable advanced or metastatic NSCLC
  • Have been confirmed as progressive disease after standard of care or for which no further standard therapy is available due to intolerance or incompatibility
  • Have been confirmed as progressive disease during or after anti-cancer therapy including programmed cell death protein 1 (PD-1) inhibitors and programmed cell death-Ligand 1 (PD-L1) inhibitors
  • IGSF1 positive expression
  • PD-L1 low or negative expression (tumor proportion score [TPS] < 50%)
  • Have measurable disease defined as at least one lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Have ECOG performance status score of 0 or 1
  • Have life expectancy ≥ 12 weeks
  • Have adequate organ functions defined as the following laboratory test criteria at screening (During the screening period, one re-test will be permitted):
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin (Hb) ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 X IULN (Not applicable to patients with Gilbert's syndrome)
  • Serum creatinine ≤ 1.5 X IULN
  • Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 2.5 X IULN (AST and ALT ≤ 5 X IULN in patients with confirmed liver metastasis)
  • Prothrombin time (PT) ≤ 1.5 X IULN *IULN: Institutional Upper Limit of Normal
  • Have provided archival tumor sample obtained within 3 months prior to IP administration or newly obtained biopsy prior to IP administration
  • Have agreed to undergo up to 2 tumor tissue biopsies after IP administration
  • Participant (or legally acceptable representative if applicable) provides written infromed consent for the trial

Who cannot join

  • [Common]
  • Have experienced hypersensitivity to IP, any of its excipients or other monoclonal antibody
  • Have any of the following documented medical history or surgical/procedure history:
  • Other primary malignant tumor (subject may be enrolled if they have neither received any treatment nor experienced disease progression within 3 years) or hematologic malignancy
  • Major surgery within 4 weeks or minor surgery within 2 weeks prior to IP administration
  • Clinically significant arrhythmia, acute myocardial infarction, unstable angina pectoris, or New York Heart Association (NYHA) class Ⅲ or Ⅳ heart failure within 6 months prior to IP administration
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  • Severe cerebrovascular disease within 6 months prior to IP administration
  • Pulmonary thrombosis, deep vein thrombosis, bronchial asthma, obstructive pulmonary disease, or other severe or life-threatening lung diseases (e.g., acute respiratory distress syndrome, lung failure) considered to be inappropriate for study participationt, within 6 months prior to IP administration
  • Pneumonia or interstitial lung disease requiring steroids
  • Infection requiring systemic antibiotics or antiviral agents, etc. or uncontorlled Grade ≥ 3 active infectious diseases within 2 weeks prior to IP administration g. Risk factors of ileus or intestinal perforation (including but not limited to history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis) h. Auto-immune diseases
  • Have any of the following diseases:
  • Central nervous system or brain metastasis that is uncontrolled or with clinically significant symptoms (except for patients who stopped systemic corticosteroids at least 4 weeks before IP administration and have been stable for at least 4 weeks)
  • Abnormal ECG regarded as clinically significant by the investigator
  • Uncontrolled hypertension (systolic blood pressure [SBP] > 160 mmHg or diastolic blood pressure [DBP] > 100 mmHg)
  • Active infection requiring treatment
  • Active hepatitis B or C virus infection
  • History of human immunodeficiency virus infection (HIV) infection
  • Symptomatic ascites or pleural effusion (except for patients who were treated and clinically stable)
  • Diseases that may affect the study results based on the judgement of the investigator
  • Have any of the following medication or treatment history:
  • Anticancer therapy (chemotherapy, hormonal therapy, targeted therapy, or radiotherapy) within 4 weeks prior to IP administration
  • Immunotherapy such as anti-PD-1, anti PD-L1, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), etc. within 4 weeks prior to IP administration
  • Treatment with live attenuated vaccine within 4 weeks prior to IP administration
  • Treatment with drugs classified as Immunosuppressants, immunomodulators, or immunocytokines within 1 week prior to IP administration (Immunosuppressants, topical corticosteroids, prednisolone 10 mg/day or ≤ equivalent dose of systemic corticosteroids may be permitted for the treatment or prevention of AEs.)
  • Allogeneic bone marrow or solid organ transplantation
  • Pregnant women, lactating women or men/women of child-bearing potential who are unwilling to maintain abstinence or use adequate methods of contraception or do not consent to refrain from donation of sperm/ova for at least 6 months after the last IP administration
  • Adequate methods of contraception
  • Oral or injectable hormonal therapy
  • Implantation of intrauterine device or intrauterine system
  • Surgical sterilization (vasectomy, tubal ligation, etc.)
  • Have received any other IP or implantation of investigational medical device within 4 weeks prior to IP administration in the present study
  • Patients who are considered ineligible or unable to participate in the study for other reasons based on the judgement of the investigator

Trial locations and contacts

2 sites in 1 country.

Wellmarker BIO contact

+82-2-6933-5667

selee@wmbio.co

South Korea2 sites, 2 recruiting

  • Incheon St. Mary's Hospital

    Incheon, Yeonsu-gu, 21999

    Ju Sang Kim

    Recruiting

  • Seoul St. Mary's Hospital

    Seoul, Seocho-gu, 06591

    Myung-Ah Lee

    Recruiting

Other trials in South Korea

About this study

Official title: An Open-label, Dose-escalation, Phase 1 Study to Investigate the Safety and Tolerability of WM-A1-3389, in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer

The purpose of the present study is to determine the safety, tolerability, and efficacy of WM-A1-3389 in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancer (NSCLC).

Being tested
WM-A1-3389, Pembrolizumab
Medical subject headings
Neoplasm Metastasis, Lung Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Cholangiocarcinoma, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WM-A1-3389Biological

    Anti-IGSF1 (Immunoglobulin superfamily member 1)

  • PembrolizumabBiological

    Also called KEYTRUDA®

    Anti-PD-1(Programmed cell death protein 1)

Study groups in NCT05872867
Study groupRoleWhat they receive
Dose escalation (Stage 1)ExperimentalWM-A1-3389 administered intravenously, weekly for 21 days of each cycle
Receives: Biological: WM-A1-3389
Dose escalation (Stage 2)ExperimentalWM-A1-3389 administered intravenously, weekly for 21 days of each cycle Pembrolizumab 200 mg administered intravenously, every 3 weeks for 21 days of each cycle
Receives: Biological: WM-A1-3389; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limit Toxicities (DLT)

    Measured: At the end of Cycle 1 (each cycle is 21 days)

  2. Number of Participants Who Experienced an Adverse Event (AE)

    Measured: Up to 6 Cycles (18 weeks)

  3. Frequency of dose discontinuation and dose reduction due to ADRs

    Measured: Up to 6 Cycles (18 weeks)

Secondary outcomes (25)

  1. Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumor (RECIST) v1.1

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  2. Disease control rate (DCR) based on RECIST v1.1

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  3. Disease control rate (DCR) based on Immune RECIST (iRECIST)

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  4. Duration of response (DOR) based on RECIST v1.1

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  5. Duration of response (DOR) based on iRECIST

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  6. Overall survival (OS)

    Measured: every 12 weeks after EOT (18 weeks)

  7. Progression free survival (PFS) based on RECIST v1.1

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  8. Progression free survival (PFS) based on iRECIST

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  9. Target tumor size

    Maximum rate of change in the sum of the maximum length of the target lesion For target tumor size, the number of subjects, average, standard deviation, median, minimum, and maximum values by each dosing group are presented.

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  10. Time to progression (TTP), time to response (TTR), time to failure (TTF), and other assessable efficacy endpoints

    Measured: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

  11. Maximum Concentration (Cmax) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  12. Maximum Concentration at steady state (Cmax,ss) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  13. Minimum Concentration (Cmin) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  14. Minimum Concentration at steady state (Cmin,ss) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  15. Average Concentration at steady state (Cav,ss) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  16. Area under the curve (AUC) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  17. Area under the curve (AUC) from 0 to infinity of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  18. Time to maximum concentration of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  19. Time to maximum concentration at steady state of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  20. Half life of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  21. Peak trough fluctuation (PTF) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  22. Accumulation ratio (AR) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  23. Clearance rate (CL) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  24. Volume of distribution (Vz) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab

    Measured: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)

  25. Number of participants with anti-WM-A1-3389 antibodies (Stage 1 only)

    Measured: Up to EOT (up to 18 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start14 Mar 2024 (estimated)
  3. Primary completion22 Feb 2026 (estimated)
  4. Study completion22 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05872867
Sponsor's protocol ID
WMA13389-101
Other IDs
MK-3475-E90, KEYNOTE-E90
Status last verified
Oct 2023
First submitted
19 Apr 2023
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WM-A1-3389 and Pembrolizumab in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Wellmarker Bio at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wellmarker BIO (+82-2-6933-5667, selee@wmbio.co), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limit Toxicities (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05872867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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