Phase 1
Completed N=138
A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
Neoplasms
Source: ClinicalTrials.gov NCT02222922 ↗
Enrolled (actual)
138
Serious AEs
35.0%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen — 0; 0; 0; 0 Participants
Summary
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen |
0; 0; 0; 0; 0; 2 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) |
2; 2; 2; 4; 96; 6 | — |
| PRIMARY Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) |
1; 1; 1; 4; 84; 5 | — |
| PRIMARY Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) |
0; 0; 1; 1; 6; 0 | — |
| PRIMARY Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen |
0; 0; 0; 1; 28; 2 | — |
| PRIMARY Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen |
0; 0; 0; 0; 8; 1 | — |
| PRIMARY Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With DLTs - Q2W Regimen |
0; 1; 2 | — |
| PRIMARY Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) |
3; 10; 12; 1; 4; 7 | — |
| PRIMARY Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) |
3; 10; 12; 0; 2; 2 | — |
| PRIMARY Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) |
0; 0; 0; 2; 3; 2 | — |
| PRIMARY Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen |
0; 3; 5; 0; 0; 4 | — |
| PRIMARY Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen |
0; 1; 2; 0; 1; 2 | — |
| PRIMARY Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen |
0; 0; 0 | — |
| PRIMARY Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen |
0; 0; 1 | — |
| SECONDARY Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen |
NA; NA; NA; 4570; 4782; 6929 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen |
NA; NA; NA; 65.77; 79.77; 96.11 | — |
| SECONDARY Clearance (CL) for PF-06647020 - Q3W Regimen |
NA; NA; NA; 0.03464; 0.03956; 0.03694 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen |
NA; NA; NA; 3.498; 3.199; 3.947 | — |
| SECONDARY Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen |
NA; NA; NA; 3.600; 3.107; 3.514 | — |
| SECONDARY Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen |
NA; NA; 1.046; 1.094; NA | — |
| SECONDARY Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen |
NA; NA; NA; 2.48; 1.08; 2.49 | — |
| SECONDARY Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen |
NA; NA; NA; 4570; 4674; 4450 | — |
| SECONDARY Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen |
NA; NA; NA; 4637; 4829; 7052 | — |
| SECONDARY AUCtau for PF-06380101 - Q3W Regimen |
NA; NA; NA; 844.6; 803.9; 1022 | — |
| SECONDARY Cmax for PF-06380101 - Q3W Regimen |
NA; NA; NA; 7.156; 6.934; 7.660 | — |
| SECONDARY t1/2 for PF-06380101 - Q3W Regimen |
NA; NA; NA; 3.150; 2.881; 3.210 | — |
| SECONDARY Rac for PF-06380101 - Q3W Regimen |
NA; NA; 0.5454; 0.8916; NA | — |
| SECONDARY Tmax for PF-06380101 - Q3W Regimen |
NA; NA; NA; 23.6; 23.9; 23.4 | — |
| SECONDARY AUClast for PF-06380101 - Q3W Regimen |
NA; NA; NA; 844.6; 799.3; 490.5 | — |
| SECONDARY AUCinf for PF-06380101 - Q3W Regimen |
NA; NA; NA; 851.4; 812.2; 1020 | — |
| SECONDARY AUCtau for hu6M024 mAb - Q3W Regimen |
NA; NA; NA; 6968; 5562; 8451 | — |
| SECONDARY Cmax for hu6M024 mAb - Q3W Regimen |
NA; NA; NA; 83.33; 84.83; 99.37 | — |
| SECONDARY t1/2 for hu6M024 mAb - Q3W Regimen |
NA; NA; NA; 4.505; 3.674; 4.386 | — |
| SECONDARY Rac for hu6M024 mAb - Q3W Regimen |
NA; NA; 1.022; 0.9865; NA | — |
| SECONDARY Tmax for hu6M024 mAb - Q3W Regimen |
NA; NA; NA; 4.00; 3.70; 2.31 | — |
| SECONDARY AUClast for hu6M024 mAb - Q3W Regimen |
NA; NA; NA; 6969; 5449; 5247 | — |
| SECONDARY AUCinf for hu6M024 mAb - Q3W Regimen |
NA; NA; NA; 7189; 5608; 8760 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen |
1; 0; 0; 0; 10; 0 | — |
| SECONDARY Percentage of Participants With Objective Response - Q3W Regimen |
16.0; 27.3; 20.7 | — |
| SECONDARY Duration of Response - Q3W Regimen |
5.7; 4.2; 4.3 | — |
| SECONDARY Disease Control Rate - Q3W Regimen |
56.0; 72.7; 48.3 | — |
| SECONDARY Time to Progression - Q3W Regimen |
2.9; 3.1; 2.2 | — |
| SECONDARY Progression Free Survival - Q3W Regimen |
2.9; 2.9; 1.5 | — |
| SECONDARY Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study] |
29.56; 23.47 | 0.3105 |
| SECONDARY Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study] |
31.51; 24.34 | 0.2316 |
| SECONDARY Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study] |
29.25; 24.85 | 0.4264 |
| SECONDARY Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study] |
0.5010; 0.4425 | 0.5123 |
| SECONDARY AUCinf(dn) for PF-06380101 [DDI Sub-Study] |
5.787; 5.275 | 0.8240 |
| SECONDARY AUClast(dn) for PF-06380101 [DDI Sub-Study] |
5.681; 5.089 | 0.7922 |
| SECONDARY AUCtau(dn) for PF-06380101 [DDI Sub-Study] |
5.746; 5.239 | 0.8240 |
| SECONDARY Cmax(dn) for PF-06380101 [DDI Sub-Study] |
0.04336; 0.04436 | 0.9553 |
| SECONDARY AUCinf(dn) for hu6M024 mAb [DDI Sub-Study] |
31.94; 25.92 | 0.2951 |
| SECONDARY AUClast(dn) for hu6M024 mAb [DDI Sub-Study] |
31.30; 26.30 | 0.3769 |
| SECONDARY AUCtau(dn) for hu6M024 mAb [DDI Sub-Study] |
31.29; 26.96 | 0.4385 |
| SECONDARY Cmax(dn) for hu6M024 mAb [DDI Sub-Study] |
0.4378; 0.3885 | 0.5678 |
| SECONDARY AUCtau for PF-06647020 - Q2W Regimen |
3627; 6541; 6319; NA; 9858; 6933 | — |
| SECONDARY Cmax for PF-06647020 -Q2W Regimen |
97.79; 99.69; 90.28; NA; 114.7; 81.91 | — |
| SECONDARY Vss for PF-06647020 - Q2W Regimen |
NA; 2.566; 2.953; NA; 2.349; 3.106 | — |
| SECONDARY CL for PF-06647020 - Q2W Regimen |
NA; 0.03075; 0.03238; NA; 0.02044; 0.02688 | — |
| SECONDARY t1/2 for PF-06647020 - Q2W Regimen |
NA; 2.700; 2.874; NA; 3.633; 3.600 | — |
| SECONDARY Rac for PF-06647020 - Q2W Regimen |
NA; 1.425; 1.211 | — |
| SECONDARY Tmax for PF-06647020 - Q2W Regimen |
3.98; 2.45; 1.05; NA; 1.07; 2.36 | — |
| SECONDARY AUClast for PF-06647020 - Q2W Regimen |
3641; 6490; 6342; NA; 9864; 7000 | — |
| SECONDARY AUCinf for PF-06647020 - Q2W Regimen |
NA; 6798; 6535; NA; 10570; 7445 | — |
| SECONDARY AUCtau for PF-06380101 - Q2W Regimen |
568.9; 860.3; 740.5; NA; 731.5; 589.8 | — |
| SECONDARY Cmax for PF-06380101 - Q2W Regimen |
6.084; 6.665; 5.779; NA; 4.857; 4.248 | — |
| SECONDARY t1/2 for PF-06380101 - Q2W Regimen |
2.507; 2.646; 2.592; NA; 2.755; 3.007 | — |
| SECONDARY Rac for PF-06380101 - Q2W Regimen |
NA; 0.9980; 0.9657 | — |
| SECONDARY Tmax for PF-06380101 - Q2W Regimen |
3.98; 4.05; 24.7; NA; 71.7; 22.8 | — |
| SECONDARY AUClast for PF-06380101- Q2W Regimen |
569.9; 866.0; 743.5; NA; 728.9; 593.3 | — |
| SECONDARY AUCinf for PF-06380101- Q2W Regimen |
584.4; 888.5; 763.2; NA; 738.8; 617.9 | — |
| SECONDARY AUCtau for hu6M024 mAb- Q2W Regimen |
4089; 7325; 6911; NA; 10440; 8432 | — |
| SECONDARY Cmax for hu6M024 mAb -Q2W Regimen |
72.04; 102.1; 86.26; NA; 106.6; 89.66 | — |
| SECONDARY t1/2 for hu6M024 mAb - Q2W Regimen |
NA; 3.436; 3.645; NA; 4.734; 4.124 | — |
| SECONDARY Rac for hu6M024 mAb - Q2W Regimen |
NA; 1.280; 1.301 | — |
| SECONDARY Tmax for hu6M024 mAb - Q2W Regimen |
3.98; 3.87; 1.05; NA; 1.05; 2.36 | — |
| SECONDARY AUClast for hu6M024 mAb - Q2W Regimen |
4103; 7368; 6949; NA; 10460; 8555 | — |
| SECONDARY AUCinf for hu6M024 mAb - Q2W Regimen |
NA; 7742; 7411; NA; 10950; 8275 | — |
| SECONDARY Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Percentage of Participants With Objective Response - Q2W Regimen |
33.3; 26.3 | — |
| SECONDARY Duration of Response - Q2W Regimen |
NA; 6.5 | — |
| SECONDARY Disease Control Rate - Q2W Regimen |
50; 84.2 | — |
| SECONDARY Time to Progression - Q2W Regimen |
2.7; 3.8 | — |
| SECONDARY Progression Free Survival - Q2W Regimen |
2.7; 3.8 | — |
Eligibility Criteria
Q2W Inclusion Criteria:
- Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
- Performance Status of 0, 1, or 2
- Adequate bone marrow, kidney, and liver function
Q2W Exclusion Criteria:
- OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
- Brain metastases requiring steroids
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
- Active and clinically significant bacterial, fungal, or viral infection
Q3W Inclusion Criteria:
- Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
- Performance Status of 0 or 1
- Adequate bone marrow, kidney, and liver function
- Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients
Q3W Exclusion Criteria:
- OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction
- Brain metastases requiring steroids
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
- Active and clinically significant bacterial, fungal, or viral infection
Data sourced from ClinicalTrials.gov (NCT02222922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.