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Ovarian CancerPhase 1NCT02539719

Study of SC-003 Alone and in Combination With ABBV-181 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer

A Phase 1 study testing SC-003 and SC-003 in combination with ABBV-181 in people with Ovarian Cancer, run by Stemcentrx at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
SC-003 and SC-003 in combination with ABBV-181
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
16 sitesUnited States
Study dates
Aug 2015to 2 Jan 2019
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed ovarian epithelial cancer
  • Evidence of progressive disease (PD) on or within 6 months of a platinum (cisplatin or carboplatin) regimen: at least 1 prior regimen must have contained a platinum-taxane combination
  • Measurable disease as defined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Fresh or archived tumor tissue sample available for target expression analysis. [Phase 1b only: Subjects' tumor tissue must test positive for target expression.]
  • Adequate hematologic and organ function as confirmed by laboratory values
  • At least 3 weeks between last systemic chemotherapy and planned start of study treatment (4 weeks for prior investigational drugs, immunotherapy, radiotherapy, or biologics) for ovarian cancer
  • At least 3 weeks between major surgery and planned start of study treatment; major incisions must have healed

Who cannot join

  • History of prior malignancy, with the exception of the following: malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician; or adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer; or adequately treated cervical carcinoma in situ without current evidence of disease.
  • Uncontrolled infection requiring systemic antibiotics/antivirals/antifungals
  • Evidence of complete or partial bowel obstruction
  • Patients requiring IV hydration or parenteral nutrition
  • Positive pregnancy test in females of child-bearing potential or pregnant or currently breastfeeding
  • Known hypersensitivity to any component of study drug including potential subjects with a history of major immunologic reaction to any IgG-containing agent
Show all 17Show fewer
  • Inability to tolerate premedication with dexamethasone
  • Uncontrolled cardiac disease, or myocardial infarction within the last 12 months, or left ventricular ejection fraction (LVEF) < 50%, or QTcF interval > 470 msec
  • Class II, III or IV heart failure as defined by the NYHA functional class system
  • Positive serology for hepatitis B or C, or known human immunodeficiency virus infection (HIV)
  • Previous treatment with a pyrrolobenzodiazepine (PBD)-based drug
  • Additional exclusion criteria for the SC-003 and ABBV-181 combination treatment regimen:
  • History of inflammatory bowel disease
  • Active autoimmune disease, with exceptions of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism
  • History of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis
  • History of immune-mediated pneumonitis
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Dallas, Texas, 75230

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Duarte, California, 91010

  • Study site

    Evanston, Illinois, 60208

  • Study site

    Fayetteville, Arkansas, 72703

  • Study site

    Houston, Texas, 77030

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10065

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Philadelphia, Pennsylvania, 19111

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: A Phase 1a/1b Dose Escalation and Expansion Study of SC-003 as a Single-Agent and in Combination With ABBV-181 in Subjects With Platinum-Resistant/ Refractory Ovarian Cancer

This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).

Read the detailed description

Phase 1a is a dose escalation study in patients with histologically/cytologically confirmed ovarian cancer that are platinum-resistant or refractory. Phase 1b is an expansion study where patients will be enrolled and treated at recommended dose and schedule based on the Phase 1a.

Conditions
Ovarian Cancer
Being tested
SC-003, SC-003 in combination with ABBV-181
Keywords
Platinum-Resistant, Refractory
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • SC-003Drug

  • SC-003 in combination with ABBV-181Drug

Study groups in NCT02539719
Study groupRoleWhat they receive
SC-003ExperimentalPhase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion
Receives: Drug: SC-003
SC-003 in combination with ABBV-181ExperimentalPhase 1a (Escalation) - IV infusion of SC-003 followed by IV infusion of ABBV-181 Phase 1b (Expansion) - IV Infusion of SC-003 followed by IV infusion of ABBV-181
Receives: Drug: SC-003 in combination with ABBV-181

What is being measured

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

  1. Adverse Events

    Measured: 18 months (Phase 1a/1b)

Secondary outcomes (8)

  1. Overall Response Rate

    Measured: 18 months (Phase 1a/1b)

  2. Pharmacokinetics of SC-003: AUC (area under the curve)

    Measured: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)

  3. Pharmacokinetics of SC-003: Cmax (maximum concentration)

    Measured: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min

  4. Pharmacokinetics of SC-003: Tmax (time of maximum concentration)

    Measured: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min

  5. Pharmacokinetics of SC-003: Ctrough (concentration at trough)

    Measured: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min

  6. Pharmacokinetics of SC-003: T1/2 (terminal half life)

    Measured: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min

  7. Pharmacokinetics of SC-003: CL (clearance)

    Measured: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min

  8. Pharmacokinetics of SC-003: Vss (volume of distribution at steady state)

    Measured: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min

Timeline

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

  1. First posted3 Sep 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion2 Jan 2019
  4. Study completion2 Jan 2019

Why it stopped: Strategic Considerations

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
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539719
Sponsor's protocol ID
SCRX003-001
Status last verified
Jan 2019
First submitted
26 Aug 2015
Last updated
4 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • Hamilton E, O'Malley DM, O'Cearbhaill R, Cristea M, Fleming GF, Tariq B, Fong A, French D, Rossi M, Brickman D, Moore K. Tamrintamab pamozirine (SC-003) in patients with platinum-resistant/refractory ovarian cancer: Findings of a phase 1 study. Gynecol Oncol. 2020 Sep;158(3):640-645. doi: 10.1016/j.ygyno.2020.05.038. Epub 2020 Jun 6.

    PubMed 32513564

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SC-003 and SC-003 in combination with ABBV-181 in people with Ovarian Cancer, run by Stemcentrx at 16 sites in United States.

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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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?

The study was stopped early (reason given: Strategic Considerations). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 18 months (Phase 1a/1b)). 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 NCT02539719, which also lists 1 linked publication.

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 4 Jan 2019.

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